Customized kit assembly for surgical implants

ABSTRACT

Methods, apparatuses, and systems for customized kit assembly for surgical implants are disclosed. A robotic surgical system designs and customizes a surgical implant and its surgical implant components. The surgical implant and its surgical implant components are assembled into a kit that is customized for a specific patient. The robotic surgical procedure using the kit can additionally select from available generic, off-the-shelf surgical implant components or customized surgical implant components.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. patent application Ser. No.17/495,395, filed Oct. 6, 2021, which is incorporated herein byreference in its entirety.

TECHNICAL FIELD

The present disclosure is generally related to automated and roboticsurgical procedures and specifically to systems and methods forproviding kit assemblies for surgical implants.

BACKGROUND

More than 200 million surgeries are performed worldwide each year, andrecent reports reveal that adverse event rates for surgical conditionsremain unacceptably high, despite traditional patient safetyinitiatives. Adverse events resulting from surgical interventions can berelated to errors occurring before or after the procedure as well astechnical surgical errors during the operation. For example, adverseevents can occur due to (i) breakdown in communication within and amongthe surgical team, care providers, patients, and their families; (ii)delay in diagnosis or failure to diagnose; and (iii) delay in treatmentor failure to treat. The risk of complications during surgery caninclude anesthesia complications, hemorrhaging, high blood pressure, arise or fall in body temperature, etc. Such adverse events can furtheroccur due to medical errors, infections, underlying physical or healthconditions of the patient, reactions to anesthetics or other drugs, etc.Conventional methods for preventing wrong-site, wrong-person,wrong-procedure errors, or retained foreign objects are typically basedon communication between the patient, the surgeon(s), and other membersof the health care team. However, conventional methods are typicallyinsufficient to prevent surgical errors and adverse events duringsurgery.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating an example surgical system, inaccordance with one or more embodiments.

FIG. 2 is a block diagram illustrating an example machine learning (ML)system, in accordance with one or more embodiments.

FIG. 3 is a block diagram illustrating an example computer system, inaccordance with one or more embodiments.

FIG. 4A is a block diagram illustrating an example robotic surgicalsystem, in accordance with one or more embodiments.

FIG. 4B illustrates an example console of the robotic surgical system ofFIG. 4A, in accordance with one or more embodiments.

FIG. 5 is a schematic block diagram illustrating subcomponents of therobotic surgical system of FIG. 4A, in accordance with one or moreembodiments.

FIG. 6 is a block diagram illustrating an example robotic surgicalsystem for customized kit assembly for surgical implants, in accordancewith one or more embodiments.

FIG. 7 is a table illustrating an example surgical implant database, inaccordance with one or more embodiments.

FIG. 8 is a flow diagram illustrating an example process for customizedkit assembly for surgical implants, in accordance with one or moreembodiments.

FIG. 9 is a flow diagram illustrating an example process for customizedkit assembly for surgical implants, in accordance with one or moreembodiments.

FIG. 10 is a flow diagram illustrating an example process for customizedkit assembly for surgical implants, in accordance with one or moreembodiments.

FIG. 11 illustrates kit components, in accordance with one or moreembodiments.

DETAILED DESCRIPTION

Embodiments of the present disclosure will be described more thoroughlyfrom now on with reference to the accompanying drawings. Like numeralsrepresent like elements throughout the several figures, and in whichexample embodiments are shown. However, embodiments of the claims can beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein. The examples set forth herein arenon-limiting examples and are merely examples, among other possibleexamples. Throughout this specification, plural instances (e.g., “602”)may implement components, operations, or structures (e.g., “602 a”)described as a single instance. Further, plural instances (e.g., “602”)refer collectively to a set of components, operations, or structures(e.g., “602 a”) described as a single instance. The description of asingle component (e.g., “602 a”) applies equally to a like-numberedcomponent (e.g., “602 b”) unless indicated otherwise. These and otheraspects, features, and implementations can be expressed as methods,apparatus, systems, components, program products, means or steps forperforming a function, and in other ways. These and other aspects,features, and implementations will become apparent from the followingdescriptions, including the claims.

A surgical implant refers to a medical device manufactured to replace amissing biological structure, support a damaged biological structure, orenhance an existing biological structure. A surgical implant can includegeneric, off-the-shelf parts as well as customized parts. While each ofoff-the-shelf parts and customized parts have their advantages, each canhave drawbacks. Generic components are typically cheaper, however, theycan be less than ideal for a particular patient and can result inuncomfortable stiffness or restricted movement. Generic parts arereadily available for emergency procedures but can require a follow upsurgery to correct problems arising from surgical implants that are notcustomized for a particular patient or application. A follow up surgerycan add cost or negatively impact a patient's wellbeing. Surgicalimplants that are customized to a patient or a specific application canoffset the drawbacks of surgical implants made from generic parts,however, customized surgical implants can be more expensive. Customizedsurgical implants may also not be readily available, requiring time todesign, construct, and then deliver the surgical implant components tobe implanted in a patient. Therefore, fully customized surgical implantscan sometimes be impractical for emergency surgery.

Customized surgical implants can include generic parts, such as fixationscrews, in addition to customized surgical implant components. Thedifferent types of surgical implant components may need to be sourcedindependently, with the generic surgical implant components beingsourced from one distributer while the customized parts are manufacturedby a different distributor or possibly even on site where theimplantation procedure takes place. Sometimes, generic surgical implantcomponents can be customized through modifications that are performed bya surgeon during the implantation procedure.

The embodiments disclosed herein describe methods, apparatuses, andsystems for customized kit assembly for surgical implants. In someembodiments, a robotic surgical system designs and customizes a surgicalimplant and its surgical implant components. The surgical implant andits surgical implant components are assembled into a kit that iscustomized for a specific patient. The robotic surgical procedure usingthe kit can additionally select from available generic, off-the-shelfsurgical implant components or customized surgical implant components.

In some embodiments, a surgical kit can be made available for a surgicalprocedure by selecting a generic surgical implant and then producing,for example, by 3D printing, a customized implant. A surgical implantcan be rigid, such as when reinforcing bone structures, or can beflexible, such as when replacing or supplementing soft tissues.Similarly, a surgical implant can be static and unmoving, or can includearticulating joints or other moveable elements. A surgical implant caninclude any of a range of materials, each of which can have differentproperties such as being rigid or flexible. Multiple materials can beutilized in the different surgical implant components or where thesurgical implant components meet to perform different functions,creating more complex implants. The implant components can be generic,off-the-shelf implant components or components that are or can bemodified or customized for a particular patient using the embodimentdescribed herein. A surgical implant can be a single piece or caninclude multiple surgical implant components. Surgical implants thatinclude multiple implant components can alternatively be referred to asassemblies. An implant can be customized to fit a particular patient ora specific application that the implant is intended for. For example, animplant can include biological donor tissues or biosynthetic tissuessuch as can be used in operations such as organ transplant, skin graft,or other tissue installation or replacement. In other examples, animplant can be any of multiple implantable medical devices, e.g.,cardiac pacemakers, electric neurological stimulation devices such asvagus nerve stimulators or deep brain stimulators, blood glucosemonitors, insulin pumps, etc.

The advantages and benefits of the methods, systems, and apparatusdisclosed herein include compatibility with best practice guidelines forperforming surgery in an operating room, e.g., from regulatory bodiesand professional standards organizations such as the Association forSurgical Technologists. The robotic surgical system disclosed provides asimplified means of assembling a kit of surgical implant components,such that a surgical implant is customized for a patient or anapplication while reducing cost. Using the embodiments disclosed, a kitof surgical implant components is provided to reduce cost whilecustomizing a surgical implant for a patient or application. Therefore,the embodiments disclosed herein make customized surgical implants moreaccessible. In addition, the embodiments consider an amount of timerequired to source surgical implant components. Hence, longer-termbeneficial patient outcomes can be achieved by balancing thecustomization of surgical implant components, when possible, with theavailability of parts and the urgency of a patient's need. For example,surgical implant components can be selected for a patient requiringemergency surgery based not only on what generic parts are on hand, butin addition by customization that can be performed on site, includingboth the modification of generic parts and the rapid manufacturing ofcustomized parts.

The robotic surgery technologies disclosed further offer valuableenhancements to medical or surgical processes through improvedprecision, stability, and dexterity. The disclosed methods relievemedical personnel from routine tasks and make medical procedures saferand less costly for patients. The embodiments disclosed enableperforming more accurate surgery in more minute locations on or withinthe human body. The embodiments also address the use of dangeroussubstances. The adoption of robotic systems, according to theembodiments disclosed herein, provides several additional benefits,including efficiency and speed improvements, lower costs, and higheraccuracy. The equipment tracking system integrated into the disclosedembodiments offers flexibility and other advantages, such as requiringno line-of-sight, reading multiple radio frequency identification (RFID)objects at once, and scanning at a distance. The advantages offered bythe surgical tower according to the embodiments disclosed herein aresmaller incisions, less pain, lower risk of infection, shorter hospitalstays, quicker recovery time, less scarring, and reduced blood loss. Theadvantages of the convolutional neural network (CNN) used for machinelearning (ML) in the disclosed embodiments include the obviation offeature extraction and the use of shared weight in convolutional layers,which means that the same filter (weights bank) is used for each node inthe layer. This both reduces memory footprint and improves performance.

FIG. 1 is a block diagram illustrating an example surgical system 100,in accordance with one or more embodiments. The system 100 includesvarious surgical and medical equipment (e.g., a patient monitor 112)located within an operating room 102 or a doctor's office 110, a console108 for performing surgery or other patient care, and a database 106 forstoring electronic health records. The console 108 is the same as orsimilar to the console 420 illustrated and described in more detail withreference to FIG. 4A. The system 100 is implemented using the componentsof the example computer system 300 illustrated and described in moredetail with reference to FIG. 3 . Likewise, embodiments of the system100 can include different and/or additional components or can beconnected in different ways.

The operating room 102 is a facility, e.g., within a hospital, wheresurgical operations are carried out in an aseptic environment. Propersurgical procedures require a sterile field. In some embodiments, thesterile field is maintained in the operating room 102 in a medical carefacility such as a hospital, the doctor's office 110, or outpatientsurgery center.

In some embodiments, the system 100 includes one or more medical orsurgical patient monitors 112. The monitors 112 can include a vitalsigns monitor (a medical diagnostic instrument), which can be aportable, battery powered, multi-parametric, vital signs monitoringdevice used for both ambulatory and transport applications as well asbedside monitoring. The vital signs monitor can be used with an isolateddata link to an interconnected portable computer or the console 108,allowing snapshot and trended data from the vital signs monitor to beprinted automatically at the console 108, and also allowing defaultconfiguration settings to be downloaded to the vital signs monitor. Thevital signs monitor is capable of use as a stand-alone unit as well aspart of a bi-directional wireless communications network that includesat least one remote monitoring station (e.g., the console 108). Thevital signs monitor can measure multiple physiologic parameters of apatient wherein various sensor output signals are transmitted eitherwirelessly or by means of a wired connection to at least one remotesite, such as the console 108.

In some embodiments, the monitors 112 include a heart rate monitor,which is a sensor and/or a sensor system applied in the context ofmonitoring heart rates. The heart rate monitor measures, directly orindirectly, any physiological condition from which any relevant aspectof heart rate can be gleaned. For example, some embodiments of the heartrate monitor measure different or overlapping physiological conditionsto measure the same aspect of heart rate. Alternatively, someembodiments measure the same, different, or overlapping physiologicalconditions to measure different aspects of heart rate, e.g., number ofbeats, strength of beats, regularity of beats, beat anomalies, etc.

In some embodiments, the monitors 112 include a pulse oximeter or SpO2monitor, which is a plethysmograph or any instrument that measuresvariations in the size of an organ or body part of the patient on thebasis of the amount of blood passing through or present in the part. Thepulse oximeter is a type of plethysmograph that determines the oxygensaturation of the blood by indirectly measuring the oxygen saturation ofthe patient's blood (as opposed to measuring oxygen saturation directlythrough a blood sample) and changes in blood volume in the skin. Thepulse oximeter can include a light sensor that is placed at a site onthe patient, usually a fingertip, toe, forehead, or earlobe, or in thecase of a neonate, across a foot. Light, which can be produced by alight source integrated into the pulse oximeter, containing both red andinfrared wavelengths, is directed onto the skin of the patient, and thelight that passes through the skin is detected by the pulse oximeter.The intensity of light in each wavelength is measured by the pulseoximeter over time. The graph of light intensity versus time is referredto as the photoplethysmogram (PPG) or, more commonly, simply as the“pleth.” From the waveform of the PPG, it is possible to identify thepulse rate of the patient and when each individual pulse occurs. Inaddition, by comparing the intensities of two wavelengths when a pulseoccurs, it is possible to determine blood oxygen saturation ofhemoglobin in arterial blood. This relies on the observation that highlyoxygenated blood will relatively absorb more red light and less infraredlight than blood with a lower oxygen saturation.

In some embodiments, the monitors 112 include an end tidal CO2 monitoror capnography monitor used for measurement of the level of carbondioxide that is released at the end of an exhaled breath (referred to asend tidal carbon dioxide, ETCO2). An end tidal CO2 monitor orcapnography monitor is widely used in anesthesia and intensive care.ETCO2 can be calculated by plotting expiratory CO2 with time. Further,ETCO2 monitors are important for the measurement of applications such ascardiopulmonary resuscitation (CPR), airway assessment, proceduralsedation and analgesia, pulmonary diseases such as obstructive pulmonarydisease, pulmonary embolism, etc., heart failure, metabolic disorders,etc. The end tidal CO2 monitor can be configured as side stream(diverting) or mainstream (non-diverting). A diverting end tidal CO2monitor transports a portion of a patient's respired gases from thesampling site to the end tidal CO2 monitor while a non-diverting endtidal CO2 monitor does not transport gas away. Also, measurement by theend tidal CO2 monitor is based on the absorption of infrared light bycarbon dioxide where exhaled gas passes through a sampling chambercontaining an infrared light source and photodetector on both sides.Based on the amount of infrared light reaching the photodetector, theamount of carbon dioxide present in the gas can be determined.

In some embodiments, the monitors 112 include a blood pressure monitorthat measures blood pressure, particularly in arteries. The bloodpressure monitor uses a non-invasive technique (by external cuffapplication) or an invasive technique (by a cannula needle inserted inartery, used in the operating room 102) for measurement. Thenon-invasive method (referred to as a sphygmomanometer) works bymeasurement of force exerted against arterial walls during ventricularsystole (i.e., systolic blood pressure occurs when the heart beats andpushes blood through the arteries) and ventricular diastole (i.e.,diastolic blood pressure occurs when the heart rests and is filling withblood) thereby measuring systole and diastole, respectively. The bloodpressure monitor can be of three types: automatic/digital, manual(aneroid-dial), and manual (mercury-column). The sphygmomanometer caninclude a bladder, a cuff, a pressure meter, a stethoscope, a valve, anda bulb. The cuff inflates until it fits tightly around the patient'sarm, cutting off the blood flow, and then the valve opens to deflate it.The blood pressure monitor operates by inflating a cuff tightly aroundthe arm; as the cuff reaches the systolic pressure, blood begins to flowin the artery, creating a vibration, which is detected by the bloodpressure monitor, which records the systolic pressure. The techniquesused for measurement can be auscultatory or oscillometric.

In some embodiments, the monitors 112 include a body temperaturemonitor. The body temperature monitor measures the temperatureinvasively or non-invasively by placement of a sensor into organs suchas bladder, rectum, esophagus, tympanum, etc., and mouth, armpit, etc.,respectively. The body temperature monitor is of two types: contact andnon-contact. Temperature can be measured in two forms: core temperatureand peripheral temperature. Temperature measurement can be done bythermocouples, resistive temperature devices (RTDs, thermistors),infrared radiators, bimetallic devices, liquid expansion devices,molecular change-of-state, and silicon diodes. A body temperaturemonitor commonly used for the measurement of temperature includes atemperature sensing element (e.g., temperature sensor) and a means forconverting to a numerical value.

In some embodiments, the monitors 112 measure respiration rate orbreathing rate, which is the rate at which breathing occurs, and whichis measured by the number of breaths the patient takes per minute. Therate is measured when a person is at rest and simply involves countingthe number of breaths for one minute by counting how many times thechest rises. Normal respiration rates for an adult patient at rest arein the range: 12 to 16 breaths per minute. A variation can be anindication of an abnormality/medical condition or the patient'sdemographic parameters. The monitors 112 can indicate hypoxia, acondition with low levels of oxygen in the cells, or hypercapnia, acondition in which high levels of carbon dioxide are in the bloodstream.Pulmonary disorders, asthma, anxiety, pneumonia, heart diseases,dehydration, and drug overdose are some abnormal conditions, which canbring a change to the respiration rate, thereby increasing or reducingthe respiration rate from normal levels.

In some embodiments, the monitors 112 measure an electrocardiogram (EKGor ECG), a representation of the electrical activity of the heart(graphical trace of voltage versus time) by placement of electrodes onskin/body surface. The electrodes capture the electrical impulse, whichtravels through the heart causing systole and diastole or the pumping ofthe heart. This impulse provides information related to the normalfunctioning of the heart and the production of impulses. A change canoccur due to medical conditions such as arrhythmias (tachycardia wherethe heart rate becomes faster and bradycardia where the heart ratebecomes slower), coronary heart disease, heart attacks, orcardiomyopathy. The instrument used for measurement of theelectrocardiogram is called an electrocardiograph which measures theelectrical impulses by the placement of electrodes on the surface of thebody and represents the ECG by a PQRST waveform. A PQRST wave is readas: P wave, which represents the depolarization of the left and rightatrium and corresponds to atrial contraction; QRS complex, whichindicates ventricular depolarization and represents the electricalimpulse as it spreads through the ventricles; and T wave, whichindicates ventricular repolarization and follows the QRS complex.

In some embodiments, the monitors 112 perform neuromonitoring, alsocalled intraoperative neurophysiological monitoring (IONM). For example,the monitors 112 assess functions and changes in the brain, brainstem,spinal cord, cranial nerves, and peripheral nerves during a surgicalprocedure on these organs. Monitoring includes both continuousmonitoring of neural tissue as well as the localization of vital neuralstructures. IONM measures changes in these organs where the changes areindicative of irreversible damage or injuries in the organs, aiming atreducing the risk of neurological deficits after operations involvingthe nervous system. Monitoring is effective in localization ofanatomical structures, including peripheral nerves and the sensorimotorcortex, which help in guiding the surgeon during dissection.Electrophysiological modalities employed in neuromonitoring are anextracellular single unit and local field recordings (LFP),somatosensory evoked potential (SSEP), transcranial electrical motorevoked potentials (TCeMEP), electromyography (EMG),electroencephalography (EEG), and auditory brainstem response (ABR). Theuse of neurophysiological monitoring during surgical procedures requiresanesthesia techniques to avoid interference and signal alteration due toanesthesia.

In some embodiments, the monitors 112 measure motor evoked potential(MEP), electrical signals that are recorded from descending motorpathways or muscles following stimulation of motor pathways within thebrain. MEP is determined by measurement of the action potential elicitedby non-invasive stimulation of the motor cortex through the scalp. MEPis for intraoperative monitoring and neurophysiological testing of themotor pathways specifically during spinal procedures. The technique ofmonitoring for measurement of MEP is defined based on parameters, suchas a site of stimulation (motor cortex or spinal cord), method ofstimulation (electrical potential or magnetic field), and site ofrecording (spinal cord or peripheral mixed nerve and muscle). The targetsite is stimulated by the use of electrical or magnetic means.

In some embodiments, the monitors 112 measure somatosensory evokedpotential (SSEP or SEP), the electrical signals generated by the brainand the spinal cord in response to sensory stimulus or touch. SSEP isused for intraoperative neurophysiological monitoring in spinalsurgeries. The measurements are reliable, which allows for continuousmonitoring during a surgical procedure. The sensor stimulus commonlygiven to the organs can be auditory, visual, or somatosensory SEPs andapplied on the skin, peripheral nerves of the upper limbs, lower limbs,or scalp. The stimulation technique can be mechanical, electrical(provides larger and more robust responses), or intraoperative spinalmonitoring modality.

In some embodiments, the monitors 112 provide electromyography (EMG),the evaluation and recording of electrical signals or electricalactivity of the skeletal muscles. An electromyography instrument,electromyograph, or electromyogram for the measurement of the EMGactivity records electrical activity produced by skeletal muscles andevaluates the functional integrity of individual nerves. The nervesmonitored by an EMG instrument can be intracranial, spinal, orperipheral nerves. The electrodes used for the acquisition of signalscan be invasive or non-invasive electrodes. The technique used formeasurement can be spontaneous or triggered. Spontaneous EMG refers tothe recording of myoelectric signals such as compression, stretching, orpulling of nerves during surgical manipulation, and does not performexternal stimulation. Spontaneous EMG is recorded by the insertion of aneedle electrode. Triggered EMG refers to the recording of myoelectricsignals during stimulation of a target site such as pedicle screw withincremental current intensities.

In some embodiments, the monitors 112 provide electroencephalography(EEG), measuring the electrical signals in the brain. Brain cellscommunicate with each other through electrical impulses. EEG can be usedto help detect potential problems associated with this activity. Anelectroencephalograph is used for the measurement of EEG activity.Electrodes ranging from 8 to 16 pairs are attached to the scalp, whereeach pair of electrodes transmits a signal to one or more recordingchannels. EEG is a modality for intraoperative neurophysiologicalmonitoring and assessing cortical perfusion and oxygenation during avariety of vascular, cardiac, and neurosurgical procedures. The wavesproduced by EEG are alpha, beta, theta, and delta.

In some embodiments, the monitors 112 include sensors, such asmicrophones or optical sensors, that produce images or video capturedfrom at least one of multiple imaging devices, for example, camerasattached to manipulators or end-effectors, cameras mounted to theceiling or other surface above the surgical theater, or cameras mountedon a tripod or other independent mounting device. In some embodiments,the cameras are body worn by a surgeon or other surgical staff, camerasare incorporated into a wearable device, such as an augmented realitydevice like Google Glass™, or cameras are integrated into an endoscopic,microscopic, or laparoscopic device. In some embodiments, a camera orother imaging device (e.g., ultrasound) present in the operating room102 is associated with one or more areas in the operating room 102. Thesensors can be associated with measuring a specific parameter of thepatient, such as respiratory rate, blood pressure, blood oxygen level,heart rate, etc.

In some embodiments, the system 100 includes a medical visualizationapparatus 114 used for visualization and analysis of objects (preferablythree-dimensional (3D) objects) in the operating room 102. The medicalvisualization apparatus 114 provides the selection of points atsurfaces, selection of a region of interest, or selection of objects.The medical visualization apparatus 114 can also be used for diagnosis,treatment planning, intraoperative support, documentation, oreducational purposes. The medical visualization apparatus 114 canfurther include microscopes, endoscopes/arthroscopes/laparoscopes, fiberoptics, surgical lights, high-definition monitors, operating roomcameras, etc. Three-dimensional (3D) visualization software providesvisual representations of scanned body parts via virtual models,offering significant depth and nuance to static two-dimensional medicalimages. The software facilitates improved diagnoses, narrowed surgicaloperation learning curves, reduced operational costs, and shortenedimage acquisition times.

In some embodiments, the system 100 includes an instrument 118 such asan endoscope, arthroscope, or laparoscope for minimally invasive surgery(MIS), in which procedures are performed by performing a minimalincision in the body. An endoscope refers to an instrument used tovisualize, diagnose, and treat problems inside hollow organs where theinstrument is inserted through natural body openings such as the mouthor anus. An endoscope can perform a procedure as follows: a scope with atiny camera attached to a long, thin tube is inserted. The doctor movesit through a body passageway or opening to see inside an organ. It canbe used for diagnosis and surgery (such as for removing polyps from thecolon). An arthroscope refers to an instrument used to visualize,diagnose, and treat problems inside a joint by a TV camera insertedthrough small portals/incisions and to perform procedures on cartilage,ligaments, tendons, etc. An arthroscope can perform the procedure asfollows: a surgeon makes a small incision in a patient's skin andinserts a pencil-sized instrument with a small lens and lighting systemto magnify the target site (joint) and viewing of the interior of thejoint by means of a miniature TV camera and then performs the procedure.A laparoscope refers to an instrument used to visualize, diagnose, andtreat problems inside soft organs like the abdomen and pelvis by a TVcamera inserted through small portals/incisions and to performprocedures.

In some embodiments, the system 100 includes fiber optics 120, whichrefer to flexible, transparent fiber made by drawing glass (silica) orplastic to a diameter slightly thicker than that of a human hair. Fiberoptics 120 are arranged in bundles called optical cables and used totransmit light signals over long distances. Fiber optics 120 are usedmost often as a means to transmit light between the two ends of thefiber and find wide usage in the medical field. Traditional surgeryrequires sizable and invasive incisions to expose internal organs andoperate on affected areas, but with fiber optics 120 much smallersurgical incisions can be performed. Fiber optics 120 contain componentssuch as a core, cladding, and buffer coating. Fiber optics 120 can beinserted in hypodermic needles and catheters, endoscopes, operationtheater tools, ophthalmological tools, and dentistry tools. Fiber opticsensors include a light source, optical fiber, external transducer, andphotodetector. Fiber optic sensors can be intrinsic or extrinsic. Fiberoptic sensors can be categorized into four types: physical, imaging,chemical, and biological.

In some embodiments, the system 100 includes surgical lights 122(referred to as operating lights) that perform illumination of a localarea or cavity of the patient. Surgical lights 122 play an importantrole in illumination before, during, and after a medical procedure.Surgical lights 122 can be categorized by lamp type as conventional(incandescent) and LED (light-emitting diode). Surgical lights 122 canbe categorized by mounting configuration as ceiling-mounted,wall-mounted, or floor stand. Surgical lights 122 can be categorized bytype as tungsten, quartz, xenon halogens, and/or LEDs. Surgical lights122 include sterilizable handles which allow the surgeon to adjust lightpositions. Some important factors affecting surgical lights 122 can beillumination, shadow management (cast shadows and contour shadows), thevolume of light, heat management, or fail-safe surgical lighting.

In some embodiments, the system 100 includes a surgical tower 128, e.g.,used in conjunction with the robotic surgical system 160 disclosedherein, for MIS. The surgical tower 128 includes instruments used forperforming MIS or surgery which is performed by creating small incisionsin the body. The instruments are also referred to as minimally invasivedevices or minimally invasive access devices. The procedure ofperforming MIS can also be referred to as a minimally invasiveprocedure. MIS is a safer, less invasive, and more precise surgicalprocedure. Some medical procedures where the surgical tower 128 isuseful and widely used are procedures for lung, gynecological, head andneck, heart, and urological conditions. MIS can be robotic ornon-robotic/endoscopic. MIS can include endoscopic, laparoscopic,arthroscopic, natural orifice intraluminal, and natural orificetransluminal procedures. A surgical tower access device can also bedesigned as an outer sleeve and an inner sleeve that telescopingly orslidably engages with one another. When a telescope is used to operateon the abdomen, the procedure is called laparoscopy. The surgical tower128 typically includes access to a variety of surgical tools, such as,for example, electrocautery, radiofrequency, lasers, sensors, etc.

In some embodiments, radiofrequency (RF) is used in association with MISdevices. The RF can be used for the treatment of skin by delivering itto the skin through a minimally invasive surgical tool (e.g., fineneedles) which does not require skin excision. The RF can be used forreal-time tracking of MIS devices such as laparoscopic instruments. TheRF can provide radiofrequency ablation to a patient suffering fromatrial fibrillation through smaller incisions made between the ribs. TheRF can be used to perform an endoscopic surgery on the body such as thespine by delivery of RF energy.

In some embodiments, the system 100 includes an instrument 130 toperform electrocautery for burning a part of the body to remove or closeoff a part of it. Various physiological conditions or surgicalprocedures require the removal of body tissues and organs, a consequenceof which is bleeding. In order to achieve hemostasis and for removingand sealing all blood vessels which are supplied to an organ aftersurgical incision, the electrocautery instrument 130 can be used. Forexample, after removing part of the liver for removal of a tumor, etc.,blood vessels in the liver must be sealed individually. Theelectrocautery instrument 130 can be used for sealing living tissue suchas arteries, veins, lymph nodes, nerves, fats, ligaments, and other softtissue structures. The electrocautery instrument 130 can be used inapplications such as surgery, tumor removal, nasal treatment, or wartremoval. Electrocautery can operate in two modes, monopolar or bipolar.The electrocautery instrument 130 can consist of a generator, ahandpiece, and one or more electrodes.

In some embodiments, the system 100 includes a laser 132 used inassociation with MIS devices. The laser 132 can be used in MIS with anendoscope. The laser 132 is attached to the distal end of the endoscopeand steered at high speed by producing higher incision quality than withexisting surgical tools and minimizing damage to surrounding tissue. Thelaser 132 can be used to perform MIS using a laparoscope in the lowerand upper gastrointestinal tract, eye, nose, and throat. The laser 132is used in MIS to ablate soft tissues, such as a herniated spinal discbulge.

In some embodiments, sensors 134 are used in association with MISdevices and the robotic surgical system 160 described herein. Thesensors 134 can be used in MIS for tactile sensing of surgicaltool—tissue interaction forces. During MIS, the field of view andworkspace of surgical tools are compromised due to the indirect accessto the anatomy and lack of surgeon's hand-eye coordination. The sensors134 provide a tactile sensation to the surgeon by providing informationof shape, stiffness, and texture of organ or tissue (differentcharacteristics) to the surgeon's hands through a sense of touch. Thisdetects a tumor through palpation, which exhibits a “tougher” feel thanthat of healthy soft tissue, pulse felt from blood vessels, and abnormallesions. The sensors 134 can output shape, size, pressure, softness,composition, temperature, vibration, shear, and normal forces. Thesensors 134 can be electrical or optical, consisting of capacitive,inductive, piezoelectric, piezoresistive, magnetic, and auditory. Thesensors 134 can be used in robotic or laparoscopic surgery, palpation,biopsy, heart ablation, and valvuloplasty.

In some embodiments, the system 100 includes an imaging system 136(instruments are used for the creation of images and visualization ofthe interior of a human body for diagnostic and treatment purposes). Theimaging system 136 is used in different medical settings and can help inthe screening of health conditions, diagnosing causes of symptoms, ormonitoring of health conditions. The imaging system 136 can includevarious imaging techniques such as X-ray, fluoroscopy, magneticresonance imaging (MRI), ultrasound, endoscopy, elastography, tactileimaging, thermography, medical photography, and nuclear medicine, e.g.,positron emission tomography (PET). Some factors which can drive themarket are cost and clinical advantages of medical imaging modalities, arising share of ageing populations, increasing prevalence ofcardiovascular or lifestyle diseases, and increasing demand fromemerging economies.

In some embodiments, the imaging system 136 includes X-ray medicalimaging instruments that use X-ray radiation (i.e., X-ray range in theelectromagnetic radiation spectrum) for the creation of images of theinterior of the human body for diagnostic and treatment purposes. AnX-ray instrument is also referred to as an X-ray generator. It is anon-invasive instrument based on different absorption of X-rays bytissues based on their radiological density (radiological density isdifferent for bones and soft tissues). For the creation of an image bythe X-ray instrument, X-rays produced by an X-ray tube are passedthrough a patient positioned to the detector. As the X-rays pass throughthe body, images appear in shades of black and white, depending on thetype and densities of tissue the X-rays pass through. Some of theapplications where X-rays are used can be bone fractures, infections,calcification, tumors, arthritis, blood vessel blockages, digestiveproblems, or heart problems. The X-ray instrument can consist ofcomponents such as an X-ray tube, operating console, collimator, grid,detector, radiographic film, etc.

In some embodiments, the imaging system 136 includes MRI medical imaginginstruments that use powerful magnets for the creation of images of theinterior of the human body for diagnostic and treatment purposes. Someof the applications where MRI can be used can be brain/spinal cordanomalies, tumors in the body, breast cancer screening, joint injuries,uterine/pelvic pain detection, or heart problems. For the creation ofthe image by an MRI instrument, magnetic resonance is produced bypowerful magnets which produce a strong magnetic field that forcesprotons in the body to align with that field. When a radiofrequencycurrent is then pulsed through the patient, the protons are stimulated,and spin out of equilibrium, straining against the pull of the magneticfield. Turning off the radiofrequency field allows detection of energyreleased by realignment of protons with the magnetic field by MRIsensors. The time taken by the protons for realignment with the magneticfield and energy release is dependent on environmental factors and thechemical nature of the molecules. MRI can more widely suit for imagingof non-bony parts or soft tissues of the body. MRI can be less harmfulas it does not use damaging ionizing radiation as in the X-rayinstrument. MRI instruments can consist of magnets, gradients,radiofrequency systems, or computer control systems. Some areas whereimaging by MRI should be prohibited can be people with implants.

In some embodiments, the imaging system 136 uses computed tomographyimaging (CT) that uses an X-ray radiation (i.e., X-ray range in theelectromagnetic radiation spectrum) for the creation of cross-sectionalimages of the interior of the human body. CT refers to a computerizedX-ray imaging procedure in which a narrow beam of X-rays is aimed at apatient and quickly rotated around the body, producing signals that areprocessed by the machine's computer to generate cross-sectionalimages—or “slices”—of the body. A CT instrument is different from anX-ray instrument as it creates 3-dimensional cross-sectional images ofthe body while the X-ray instrument creates 2-dimensional images of thebody; the 3-dimensional cross-sectional images are created by takingimages from different angles, which is done by taking a series oftomographic images from different angles. The diverse images arecollected by a computer and digitally stacked to form a 3-dimensionalimage of the patient. For creation of images by the CT instrument, a CTscanner uses a motorized X-ray source that rotates around the circularopening of a donut-shaped structure called a gantry while the X-ray tuberotates around the patient shooting narrow beams of X-rays through thebody. Some of the applications where CT can be used can be blood clots;bone fractures, including subtle fractures not visible on X-ray; ororgan injuries.

In some embodiments, the imaging system 136 includes ultrasound imaging,also referred to as sonography or ultrasonography, that uses ultrasoundor sound waves (also referred to as acoustic waves) for the creation ofcross-sectional images of the interior of the human body. Ultrasoundwaves in the imaging system 136 can be produced by a piezoelectrictransducer which produces sound waves and sends them into the body. Thesound waves that are reflected are converted into electrical signalswhich are sent to an ultrasound scanner. Ultrasound instruments can beused for diagnostic and functional imaging or for therapeutic orinterventional procedures. Some of the applications where ultrasound canbe used are diagnosis/treatment/guidance during medical procedures(e.g., biopsies, internal organs such as liver/kidneys/pancreas, fetalmonitoring, etc.), in soft tissues, muscles, blood vessels, tendons, orjoints. Ultrasound can be used for internal imaging (where thetransducer is placed in organs, e.g., vagina) and external imaging(where the transducer is placed on the chest for heart monitoring or theabdomen for the fetal monitoring). An ultrasound machine can consist ofa monitor, keyboard, processor, data storage, probe, and transducer.

In some embodiments, the system 100 includes a stereotactic navigationsystem 138 that uses patient imaging (e.g., CT, MRI) to guide surgeonsin the placement of specialized surgical instruments and implants. Thepatient images are taken to guide the physician before or during themedical procedure. The stereotactic navigation system 138 includes acamera having infrared sensors to determine the location of the tip ofthe probe being used in the surgical procedure. This information is sentin real-time so that the surgeons have a clear image of the preciselocation where they are working in the body. The stereotactic navigationsystem 138 can be framed (requires attachment of a frame to thepatient's head using screws or pins) or frameless (does not require theplacement of a frame on the patient's anatomy). The stereotacticnavigation system 138 can be used for diagnostic biopsies, tumorresection, bone preparation/implant placement, placement of electrodes,otolaryngologic procedures, or neurosurgical procedures.

In some embodiments, the system 100 includes an anesthesiology machine140 that is used to generate and mix medical gases, such as oxygen orair, and anesthetic agents to induce and maintain anesthesia inpatients. The anesthesiology machine 140 delivers oxygen and anestheticgas to the patient and filters out expiratory carbon dioxide. Theanesthesiology machine 140 can perform functions such as providingoxygen (O2), accurately mixing anesthetic gases and vapors, enablingpatient ventilation, and minimizing anesthesia-related risks to patientsand staff. The anesthesiology machine 140 can include the followingessential components: a source of O2, O2 flowmeter, vaporizer(anesthetics include isoflurane, halothane, enflurane, desflurane,sevoflurane, and methoxyflurane), patient breathing circuit (tubing,connectors, and valves), and scavenging system (removes any excessanesthetics gases). The anesthesiology machine 140 can be divided intothree parts: the high pressure system, the intermediate pressure system,and the low pressure system. The process of anesthesia starts withoxygen flow from a pipeline or cylinder through the flowmeter; the O2flows through the vaporizer and picks up the anesthetic vapors; theO2-anesthetic mix then flows through the breathing circuit and into thepatient's lungs, usually by spontaneous ventilation or normalrespiration.

In some embodiments, the system 100 includes a surgical bed 142 equippedwith mechanisms that can elevate or lower the entire bed platform; flex,or extend individual components of the platform; or raise or lower thehead or the feet of the patient independently. The surgical bed 142 canbe an operation bed, cardiac bed, amputation bed, or fracture bed. Someessential components of the surgical bed 142 can be a bed sheet, woolenblanket, bath towel, and bed block. The surgical bed 142 can also bereferred to as a postoperative bed, which refers to a special type ofbed made for the patient who is coming from the operation theater orfrom another procedure that requires anesthesia. The surgical bed 142 isdesigned in a manner that makes it easier to transfer an unconscious orweak patient from a stretcher/wheelchair to the bed. The surgical bed142 should protect bed linen from vomiting, bleeding, drainage, anddischarge; provide warmth and comfort to the patient to prevent shock;provide necessary positions, which are suitable for operation; protectpatient from being chilled; and be prepared to meet any emergency.

In some embodiments, the system 100 includes a Jackson frame 144 (orJackson table), which refers to a frame or table which is designed foruse in spinal surgeries and can be used in a variety of spinalprocedures in supine, prone, or lateral positions in a safe manner. Twopeculiar features of the Jackson table 144 are no central table supportand an ability to rotate the table through 180 degrees. The Jacksontable 144 is supported at both ends which keeps the whole of the tablefree. This allows the visualization of a patient's trunk and major partsof extremities as well. The Jackson frame 144 allows the patient to beslid from the cart onto the table in the supine position withappropriate padding placed. The patient is then strapped securely on theJackson table 144.

In some embodiments, the system 100 includes a disposable air warmer 146(sometimes referred to as a Bair™ or Bair Hugger™). The disposable airwarmer 146 is a convective temperature management system used in ahospital or surgery center to maintain a patient's core bodytemperature. The disposable air warmer 146 includes a reusable warmingunit and a single-use disposable warming blanket for use during surgery.It can also be used before and after surgery. The disposable air warmer146 uses convective warming consisting of two components: a warming unitand a disposable blanket. The disposable air warmer 146 filters air andthen forces warm air through disposable blankets which cover thepatient. The blanket can be designed to use pressure points on thepatient's body to prevent heat from reaching areas at risk for pressuresores or burns. The blanket can also include drain holes where fluidpasses through the surface of the blanket to linen underneath which willreduce the risk of skin softening and reduce the risk of unintendedcooling because of heat loss from evaporation.

In some embodiments, the system 100 includes a sequential compressiondevice (SCD) 148 used to help prevent blood clots in the deep veins oflegs. The sequential compression device 148 uses cuffs around the legsthat fill with air and squeeze the legs. This increases blood flowthrough the veins of the legs and helps prevent blood clots. A deep veinthrombosis (DVT) is a blood clot that forms in a vein deep inside thebody. Some of the risks of using the SCD 148 can be discomfort, warmth,sweating beneath the cuff, skin breakdown, nerve damage, or pressureinjury.

In some embodiments, the system 100 includes a bed position controller150, which refers to an instrument for controlling the position of thepatient bed. Positioning a patient in bed is important for maintainingalignment and for preventing bedsores (pressure ulcers), foot drop, andcontractures. Proper positioning is also vital for providing comfort forpatients who are bedridden or have decreased mobility related to amedical condition or treatment. When positioning a patient in bed,supportive devices such as pillows, rolls, and blankets, along withrepositioning, can aid in providing comfort and safety. The patient canbe in the following positions in a bed: supine position, prone position,lateral position, Sims' position, Fowler's position, semi-Fowler'sposition, orthopedic or tripod position, or Trendelenburg position.

In some embodiments, the system 100 includes environmental controls 152.The environmental controls 152 can be operating room environmentalcontrols for control or maintenance of the environment in the operatingroom 102 where procedures are performed to minimize the risk of airborneinfection and to provide a conducive environment for everyone in theoperating room 102 (e.g., surgeon, anesthesiologist, nurses, andpatient). Some factors which can contribute to poor quality in theenvironment of the operating room 102 are temperature, ventilation, andhumidity, and those conditions can lead to profound effects on thehealth and work productivity of people in the operating room 102. As anexample: surgeons prefer a cool, dry climate since they work in bright,hot lights; anesthesia personnel prefer a warmer, less breezy climate;patient condition demands a relatively warm, humid, and quietenvironment. The operating room environmental controls can control theenvironment by taking care of the following factors: environmentalhumidity, infection control, or odor control. Humidity control can beperformed by controlling the temperature of anesthesia gases; infectioncan be controlled by the use of filters to purify the air.

In some embodiments, the environmental controls 152 include a heating,ventilation, and air conditioning (HVAC) system for regulating theenvironment of indoor settings by moving air between indoor and outdoorareas, along with heating and cooling. HVAC can use a differentcombination of systems, machines, and technologies to improve comfort.HVAC can be necessary to maintain the environment of the operating room102. The operating room 102 can be a traditional operating room (whichcan have a large diffuser array directly above the operating table) or ahybrid operating room (which can have monitors and imaging equipment 136that consume valuable ceiling space and complicate the design process).HVAC can include three main units, for example, a heating unit (e.g.,furnace or boiler), a ventilation unit (natural or forced), and an airconditioning unit (which can remove existing heat). HVAC can be made ofcomponents such as air returns, filters, exhaust outlets, ducts,electrical elements, outdoor units, compressors, coils, and blowers. TheHVAC system can use central heating and AC systems that use a singleblower to circulate air via internal ducts.

In some embodiments, the environmental controls 152 include an airpurification system for removing contaminants from the air in theoperating room 102 to improve indoor air quality. Air purification canbe important in the operating room 102 as surgical site infection can bea reason for high mortality and morbidity. The air purification systemcan deliver clean, filtered, contaminant-free air over the surgical bed142 using a diffuser, airflow, etc., to remove all infectious particlesdown and away from the patient. The air purification system can be anair curtain, multi-diffuser array, or single large diffuser (based onlaminar diffuser flow) or High-Efficiency Particulate Air filter.High-Efficiency Particulate Air filter (HEPA filter) protects frominfection and contamination by a filter which is mounted at the terminalof the duct. A HEPA filter can be mounted on the ceiling and deliverclean, filtered air in a flow to the operating room 102 that provides asweeping effect that pushes contaminants out via the return grilles thatare usually mounted on the lower wall.

In some embodiments, the system 100 includes one or more medical orsurgical tools 154. The surgical tools 154 can include orthopedic tools(also referred to as orthopedic instruments) used for treatment andprevention of deformities and injuries of the musculoskeletal system orskeleton, articulations, and locomotive system (i.e., set formed byskeleton, muscles attached to it, and the part of the nervous systemwhich controls the muscles). A major percentage of orthopedic tools aremade of plastic. The orthopedic tools can be divided into the followingspecialties: hand and wrist, foot and ankle, shoulder and elbow,arthroscopic, hip, and knee. The orthopedic tools can be fixation tools,relieving tools, corrective tools, or compression-distraction tools. Afixation tool refers to a tool designed to restrict movements partiallyor completely in a joint, e.g., hinged splints (for preserving a certainrange of movement in a joint) or rigid splints. A relieving tool refersto a tool designed to relieve pressure on an ailing part by transferringsupport to healthy parts of an extremity, e.g., Thomas splint and theVoskoboinikova apparatus. A corrective tool refers to a surgical tooldesigned to gradually correct a deformity, e.g., corsets, splints,orthopedic footwear, insoles, and other devices to correct abnormalpositions of the foot. A compression-distraction tool refers to asurgical tool designed to correct acquired or congenital deformities ofthe extremities, e.g., curvature, shortening, and pseudarthrosis such asGudushauri. A fixation tool can be an internal fixation tool (e.g.,screws, plates) or external fixation tools used to correct a radius ortibia fracture. The orthopedic tools can be bone-holding forceps, drillbits, nail pins, hammers, staples, etc.

In some embodiments, the surgical tools 154 include a drill for makingholes in bones for insertion of implants like nails, plates, screws, andwires. The drill tool functions by drilling cylindrical tunnels intobone. Drills can be used in orthopedics for performing medicalprocedures. If the drill does not stop immediately when used, the use ofthe drill on bones can have some risks, such as harm caused to bone,muscle, nerves, and venous tissues, which are wrapped by surroundingtissue. Drills vary widely in speed, power, and size. Drills can bepowered as electrical, pneumatic, or battery. Drills generally can workon speeds below 1000 rpm in orthopedic settings. Temperature control ofdrills is an important aspect in the functioning of the drill and isdependent on parameters such as rotation speed, torque, orthotropicsite, sharpness of the cutting edges, irrigation, and cooling systems.The drill can include a physical drill, power cord, electronicallymotorized bone drill, or rotating bone shearing incision work unit.

In some embodiments, the surgical tools 154 include a scalpel forslicing, cutting, or osteotomy of bone during orthopedic procedure. Thescalpel can be designed to provide clean cuts through osseous structureswith minimal loss of viable bone while sparing adjacent elastic softtissues largely unaffected while performing a slicing procedure. This issuited for spine applications where bone must be cut adjacent to thedura and neural structures. The scalpel does not rotate but performscutting by an ultrasonically oscillating or forward/backward movingmetal tip. Scalpels can prevent injuries caused by a drill in a spinalsurgery such as complications such as nerve thermal injury, graspingsoft tissue, tearing dura mater, and mechanical injury.

In some embodiments, stitches (also referred to as sutures) or asterile, surgical thread is used to repair cuts or lacerations and isused to close incisions or hold body tissues together after a surgery oran injury. Stitches can involve the use of a needle along with anattached thread. Stitches can be of type absorbable (the stitchesautomatically break down harmlessly in the body over time withoutintervention) and non-absorbable (the stitches do not automaticallybreak down over time and must be manually removed if not leftindefinitely). Stitches can be based on material monofilament,multifilament, and barb. Stitches can be classified based on size.Stitches can be based on synthetic or natural material. Stitches can becoated or un-coated.

In some embodiments, the surgical tools 154 include a stapler used forfragment fixation when inter-fragmental screw fixation is not easy. Whenthere is vast damage and a bone is broken into fragments, staples can beused between these fragments for internal fixation and bonereconstruction. For example, they can be used around joints in ankle andfoot surgeries, in cases of soft tissue damage, or to attach tendons orligaments to the bone for reconstruction surgery. Staplers can be madeof surgical grade stainless steel or titanium, and they are thicker,stronger, and larger.

In some embodiments, other medical or surgical equipment, such as a setof articles, surgical tools, or objects, is used to implement or achievean operation or activity. A medical equipment refers to an article,instrument, apparatus, or machine used for diagnosis, prevention, ortreatment of a medical condition or disease, or to the detection,measurement, restoration, correction, or modification ofstructure/function of the body for some health purpose. The medicalequipment can perform functions invasively or non-invasively. In someembodiments, the medical equipment includes components such assensor/transducer, signal conditioner, display, data storage unit, etc.In some embodiments, the medical equipment includes a sensor to receivea signal from a measurand/patient; a transducer for converting one formof energy to electrical energy; a signal conditioner such as anamplifier, filter, etc., to convert the output from the transducer intoan electrical value; a display to provide a visual representation of themeasured parameter or quantity; and a storage system to store data whichcan be used for future reference. A medical equipment can performdiagnosis or provide therapy; for example, the equipment delivers airinto the lungs of a patient who is physically unable to breathe, orbreathes insufficiently, and moves it out of the lungs.

In some embodiments, the system includes a machine 156 to aid inbreathing. The machine 156 can be a ventilator (also referred to as arespirator) that provides a patient with oxygen when they are unable tobreathe on their own. A ventilator is required when a person is not ableto breathe on their own. A ventilator can perform a function of gentlypushing air into the lungs and allows it to come back out. Theventilator functions by delivery of positive pressure to force air intothe lungs, while usual breathing uses negative pressure by the openingof the mouth, and air flows in. The ventilator can be required duringsurgery or after surgery. The ventilator can be required in case ofrespiratory failure due to acute respiratory distress syndrome, headinjury, asthma, lung diseases, drug overdose, neonatal respiratorydistress syndrome, pneumonia, sepsis, spinal cord injury, cardiacarrest, etc., or during surgery. The ventilator can be used with a facemask (non-invasive ventilation, where the ventilation is required for ashorter duration of time) or with a breathing tube also referred to asan endotracheal tube (invasive ventilation, where the ventilation isrequired for a longer duration of time). Ventilator use can have somerisks such as infections, fluid build-up, muscle weakness, lung damage,etc. The ventilator can be operated in various modes, such asassist-control ventilation (ACV), synchronized intermittent-mandatoryventilation (SIMV), pressure-controlled ventilation (PCV), pressuresupport ventilation (PSV), pressure-controlled inverse ratio ventilation(PCIRV), airway pressure release ventilation (APRV), etc. The ventilatorcan include a gas delivery system, power source, control system, safetyfeature, gas filter, and monitor.

In some embodiments, the machine 156 is a continuous positive airwaypressure (CPAP) used for the treatment of sleep apnea disorder in apatient. Sleep apnea refers to a disorder in which breathing repeatedlystops and starts while a patient is sleeping, often becausethroat/airways briefly collapse or something temporarily blocks them.Sleep apnea can lead to serious health problems, such as high bloodpressure and heart trouble. A CPAP instrument helps the patient withsleep apnea to breathe more easily during sleep by sending a steady flowof oxygen into the nose and mouth during sleep, which keeps the airwaysopen and helps the patient to breathe normally. The CPAP machine canwork by a compressor/motor which generates a continuous stream ofpressurized air which travels through an air filter into a flexibletube. The tube delivers purified air into a mask sealed around thenose/mouth of the patient. The airstream from the instrument pushesagainst any blockages, opening the airways so lungs receive plenty ofoxygen, and breathing does not stop as nothing obstructs oxygen. Thishelps the patient to not wake up to resume breathing. CPAP can have anasal pillow mask, nasal mask, or full mask. CPAP instrument can includea motor, a cushioned mask, a tube that connects the motor to the mask, aheadgear frame, and adjustable straps. The essential components can be amotor, a cushioned mask, and a tube that connects the motor to the mask.

In some embodiments, the system 100 includes surgical supplies,consumables 158, or necessary supplies for the system 100 to providecare within the hospital or surgical environment 102. The consumables158 can include gloves, gowns, masks, syringes, needles, sutures,staples, tubing, catheters, or adhesives for wound dressing, in additionto other surgical tools needed by doctors and nurses to provide care.Depending on the device, mechanical testing can be carried out intensile, compression, or flexure; in dynamic or fatigue; via impact; orwith the application of torsion. The consumables 158 can be disposable(e.g., time-saving, have no risk of healthcare-associated infections,and cost-efficient) or sterilizable (to avoid cross-contamination orrisk of surgical site infections).

In some embodiments, the system 100 includes a robotic surgical system160 (sometimes referred to as a medical robotic system or a roboticsystem) that provides intelligent services and information to theoperating room 102 and the console 108 by interacting with theenvironment, including human beings, via the use of various sensors,actuators, and human interfaces. The robotic surgical system 160 can beemployed for automating processes in a wide range of applications,ranging from industrial (manufacturing), domestic, medical, service,military, entertainment, space, etc. The medical robotic system marketis segmented by product type into surgical robotic systems,rehabilitative robotic systems, non-invasive radiosurgery robots, andhospital and pharmacy robotic systems. Robotic surgeries are performedusing tele-manipulators (e.g., input devices 166 at the console 108),which use the surgeon's actions on one side to control one or more“effectors” on the other side. The medical robotic system 160 providesprecision and can be used for remotely controlled, minimally invasiveprocedures. The robotic surgical system 160 includes computer-controlledelectromechanical devices that work in response to controls (e.g., inputdevices 166 at the console 108) manipulated by the surgeons.

In some embodiments, the system 100 includes equipment tracking systems162, such as RFID, which is used to tag an instrument with an electronictag and tracks it using the tag. Typically, this could involve acentralized platform that provides details such as location, owner,contract, and maintenance history for all equipment in real-time. Avariety of techniques can be used to track physical assets, includingRFID, global positioning system (GPS), Bluetooth low energy (BLE),barcodes, near-field communication (NFC), Wi-Fi, etc. The equipmenttracking system 162 includes hardware components, such as RFID tags, GPStrackers, barcodes, and QR codes. The hardware component is placed onthe asset, and it communicates with the software (directly or via ascanner), providing the software with data about the asset's locationand properties. In some embodiments, the equipment tracking system 162uses electromagnetic fields to transmit data from an RFID tag to areader. Reading of RFID tags can be done by portable or mounted RFIDreaders. The read range for RFID varies with the frequency used.Managing and locating important assets is a key challenge for trackingmedical equipment. Time spent searching for critical equipment can leadto expensive delays or downtime, missed deadlines and customercommitments, and wasted labor. The problem has previously been solved byusing barcode labels or manual serial numbers and spreadsheets; however,these require manual labor. The RFID tag can be passive (smaller andless expensive, read ranges are shorter, have no power of their own, andare powered by the radio frequency energy transmitted from RFIDreaders/antennas) or active (larger and more expensive, read ranges arelonger, have a built-in power source and transmitter of their own).

In some embodiments, the system 100 includes medical equipment,computers, software, etc., located in the doctor's office 110 that iscommunicably coupled to the operating room 102 over the network 104. Forexample, the medical equipment in the doctor's office 110 can include amicroscope 116 used for viewing samples and objects that cannot be seenwith an unaided eye. The microscope 116 can have components such aseyepieces, objective lenses, adjustment knobs, a stage, an illuminator,a condenser, or a diaphragm. The microscope 116 works by manipulatinghow light enters the eye using a convex lens, where both sides of thelens are curved outwards. When light reflects off of an object beingviewed under the microscope 116 and passes through the lens, it bendstoward the eye. This makes the object look bigger than it is. Themicroscope 116 can be compound (light-illuminated and the image seenwith the microscope 116 is two-dimensional), dissection or stereoscope(light-illuminated and the image seen with the microscope 116 isthree-dimensional), confocal (laser-illuminated and the image seen withthe microscope 116 is on a digital computer screen), scanning electron(SEM) (electron-illuminated and the image seen with the microscope 116is in black and white), or transmission electron microscope (TEM)(electron-illuminated and the image seen with the microscope 116 is thehigh magnification and high resolution).

The system 100 includes an electronic health records (EHR) database 106that contains patient records. The EHR are a digital version ofpatients' paper charts. The EHR database 106 can contain moreinformation than a traditional patient chart, including, but not limitedto, a patients' medical history, diagnoses, medications, treatmentplans, allergies, diagnostic imaging, lab results, etc. In someembodiments, the steps for each procedure disclosed herein are stored inthe EHR database 106. Electronic health records can also include datacollected from the monitors 112 from historical procedures. The EHRdatabase 106 is implemented using components of the example computersystem 300 illustrated and described in more detail with reference toFIG. 3 .

In some embodiments, the EHR database 106 includes a digital record ofpatients' health information, collected and stored systematically overtime. The EHR database 106 can include demographics, medical history,history of present illness (HPI), progress notes, problems, medications,vital signs, immunizations, laboratory data, or radiology reports.Software (in memory 164) operating on the console 108 or implemented onthe example computer system 300 (e.g., the instructions 304, 308illustrated and described in more detail with reference to FIG. 3 ) areused to capture, store, and share patient data in a structured way. TheEHR database 106 can be created and managed by authorized providers andcan make health information accessible to authorized providers acrosspractices and health organizations, such as laboratories, specialists,medical imaging facilities, pharmacies, emergency facilities, etc. Thetimely availability of EHR data enables healthcare providers to makemore accurate decisions and provide better care to the patients byeffective diagnosis and reduced medical errors. Besides providingopportunities to enhance patient care, the EHR database 106 can also beused to facilitate clinical research by combining patients' demographicsinto a large pool. For example, the EHR database 106 can support a widerange of epidemiological research on the natural history of disease,drug utilization, and safety, as well as health services research.

The console 108 is a computer device, such as a server, computer,tablet, smartphone, smart speaker, etc., implemented using components ofthe example computer system 300 illustrated and described in more detailwith reference to FIG. 3 . In some embodiments, the steps for eachprocedure disclosed herein are stored in memory 164 on the console 108for execution.

In some embodiments, the operating room 102 or the console 108 includeshigh-definition monitors 124, which refer to displays in which a clearerpicture is possible than with low-definition, low-resolution screens.The high-definition monitors 124 have a higher density of pixels perinch than past standard TV screens. Resolution for the high-definitionmonitors 124 can be 1280×720 pixels or more (e.g., Full HD, 1920×1080;Quad HD, 2560×1440; 4K, 3840×2160; 8K, 7680×4320 pixels). Thehigh-definition monitor 124 can operate in progressive or interlacedscanning mode. High-definition monitors used in medical applications canoffer improved visibility; allow for precise and safe surgery with richcolor reproduction; provide suitable colors for each clinicaldiscipline; provide better visibility, operability with a large screenand electronic zoom, higher image quality in low light conditions,better visualization of blood vessels and lesions, and high contrast athigh spatial frequencies; be twice as sensitive as conventional sensors;and make it easier to determine tissue boundaries (fat, nerves, vessels,etc.).

In some embodiments, the console 108 includes an input interface or oneor more input devices 166. The input devices 166 can include a keyboard,a mouse, a joystick, any hand-held controller, or a hand-controlledmanipulator, e.g., a tele-manipulator used to perform robotic surgery.

In some embodiments, the console 108, the equipment in the doctor'soffice 110, and the EHR database 106 are communicatively coupled to theequipment in the operating room 102 by a direct connection, such asethernet, or wirelessly by the cloud over the network 104. The network104 is the same as or similar to the network 314 illustrated anddescribed in more detail with reference to FIG. 3 . For example, theconsole 108 can communicate with the robotic surgical system 160 usingthe network adapter 312 illustrated and described in more detail withreference to FIG. 3 .

FIG. 2 is a block diagram illustrating an example machine learning (ML)system 200, in accordance with one or more embodiments. The ML system200 is implemented using components of the example computer system 300illustrated and described in more detail with reference to FIG. 3 . Forexample, the ML system 200 can be implemented on the console 108 usinginstructions programmed in the memory 164 illustrated and described inmore detail with reference to FIG. 1 . Likewise, embodiments of the MLsystem 200 can include different and/or additional components or beconnected in different ways. The ML system 200 is sometimes referred toas a ML module.

The ML system 200 includes a feature extraction module 208 implementedusing components of the example computer system 300 illustrated anddescribed in more detail with reference to FIG. 3 . In some embodiments,the feature extraction module 208 extracts a feature vector 212 frominput data 204. For example, the input data 204 can include one or morephysiological parameters measured by the monitors 112 illustrated anddescribed in more detail with reference to FIG. 1 . The feature vector212 includes features 212 a, 212 b, . . . , 212 n. The featureextraction module 208 reduces the redundancy in the input data 204,e.g., repetitive data values, to transform the input data 204 into thereduced set of features 212, e.g., features 212 a, 212 b, . . . , 212 n.The feature vector 212 contains the relevant information from the inputdata 204, such that events or data value thresholds of interest can beidentified by the ML model 216 by using this reduced representation. Insome example embodiments, the following dimensionality reductiontechniques are used by the feature extraction module 208: independentcomponent analysis, Isomap, kernel principal component analysis (PCA),latent semantic analysis, partial least squares, PCA, multifactordimensionality reduction, nonlinear dimensionality reduction,multilinear PCA, multilinear subspace learning, semidefinite embedding,autoencoder, and deep feature synthesis.

In alternate embodiments, the ML model 216 performs deep learning (alsoknown as deep structured learning or hierarchical learning) directly onthe input data 204 to learn data representations, as opposed to usingtask-specific algorithms. In deep learning, no explicit featureextraction is performed; the features 212 are implicitly extracted bythe ML system 200. For example, the ML model 216 can use a cascade ofmultiple layers of nonlinear processing units for implicit featureextraction and transformation. Each successive layer uses the outputfrom the previous layer as input. The ML model 216 can thus learn insupervised (e.g., classification) and/or unsupervised (e.g., patternanalysis) modes. The ML model 216 can learn multiple levels ofrepresentations that correspond to different levels of abstraction,wherein the different levels form a hierarchy of concepts. In thismanner, the ML model 216 can be configured to differentiate features ofinterest from background features.

In alternative example embodiments, the ML model 216, e.g., in the formof a CNN generates the output 224, without the need for featureextraction, directly from the input data 204. The output 224 is providedto the computer device 228 or the console 108 illustrated and describedin more detail with reference to FIG. 1 . The computer device 228 is aserver, computer, tablet, smartphone, smart speaker, etc., implementedusing components of the example computer system 300 illustrated anddescribed in more detail with reference to FIG. 3 . In some embodiments,the steps performed by the ML system 200 are stored in memory on thecomputer device 228 for execution. In other embodiments, the output 224is displayed on the high-definition monitors 124 illustrated anddescribed in more detail with reference to FIG. 1 .

A CNN is a type of feed-forward artificial neural network in which theconnectivity pattern between its neurons is inspired by the organizationof a visual cortex. Individual cortical neurons respond to stimuli in arestricted region of space known as the receptive field. The receptivefields of different neurons partially overlap such that they tile thevisual field. The response of an individual neuron to stimuli within itsreceptive field can be approximated mathematically by a convolutionoperation. CNNs are based on biological processes and are variations ofmultilayer perceptrons designed to use minimal amounts of preprocessing.

The ML model 216 can be a CNN that includes both convolutional layersand max pooling layers. The architecture of the ML model 216 can be“fully convolutional,” which means that variable sized sensor datavectors can be fed into it. For all convolutional layers, the ML model216 can specify a kernel size, a stride of the convolution, and anamount of zero padding applied to the input of that layer. For thepooling layers, the model 216 can specify the kernel size and stride ofthe pooling.

In some embodiments, the ML system 200 trains the ML model 216, based onthe training data 220, to correlate the feature vector 212 to expectedoutputs in the training data 220. As part of the training of the MLmodel 216, the ML system 200 forms a training set of features andtraining labels by identifying a positive training set of features thathave been determined to have a desired property in question, and, insome embodiments, forms a negative training set of features that lackthe property in question.

The ML system 200 applies ML techniques to train the ML model 216, thatwhen applied to the feature vector 212, outputs indications of whetherthe feature vector 212 has an associated desired property or properties,such as a probability that the feature vector 212 has a particularBoolean property, or an estimated value of a scalar property. The MLsystem 200 can further apply dimensionality reduction (e.g., via lineardiscriminant analysis (LDA), PCA, or the like) to reduce the amount ofdata in the feature vector 212 to a smaller, more representative set ofdata.

The ML system 200 can use supervised ML to train the ML model 216, withfeature vectors of the positive training set and the negative trainingset serving as the inputs. In some embodiments, different ML techniques,such as linear support vector machine (linear SVM), boosting for otheralgorithms (e.g., AdaBoost), logistic regression, naïve Bayes,memory-based learning, random forests, bagged trees, decision trees,boosted trees, boosted stumps, neural networks, CNNs, etc., are used. Insome example embodiments, a validation set 232 is formed of additionalfeatures, other than those in the training data 220, which have alreadybeen determined to have or to lack the property in question. The MLsystem 200 applies the trained ML model 216 to the features of thevalidation set 232 to quantify the accuracy of the ML model 216. Commonmetrics applied in accuracy measurement include: Precision and Recall,where Precision refers to a number of results the ML model 216 correctlypredicted out of the total it predicted, and Recall is a number ofresults the ML model 216 correctly predicted out of the total number offeatures that had the desired property in question. In some embodiments,the ML system 200 iteratively re-trains the ML model 216 until theoccurrence of a stopping condition, such as the accuracy measurementindication that the ML model 216 is sufficiently accurate, or a numberof training rounds having taken place.

FIG. 3 is a block diagram illustrating an example computer system, inaccordance with one or more embodiments. Components of the examplecomputer system 300 can be used to implement the monitors 112, theconsole 108, or the EHR database 106 illustrated and described in moredetail with reference to FIG. 1 . In some embodiments, components of theexample computer system 300 are used to implement the ML system 200illustrated and described in more detail with reference to FIG. 2 . Atleast some operations described herein can be implemented on thecomputer system 300.

The computer system 300 can include one or more central processing units(“processors”) 302, main memory 306, non-volatile memory 310, networkadapters 312 (e.g., network interface), video displays 318, input/outputdevices 320, control devices 322 (e.g., keyboard and pointing devices),drive units 324 including a storage medium 326, and a signal generationdevice 320 that are communicatively connected to a bus 316. The bus 316is illustrated as an abstraction that represents one or more physicalbuses and/or point-to-point connections that are connected byappropriate bridges, adapters, or controllers. The bus 316, therefore,can include a system bus, a Peripheral Component Interconnect (PCI) busor PCI-Express bus, a HyperTransport or industry standard architecture(ISA) bus, a small computer system interface (SCSI) bus, a universalserial bus (USB), IIC (I2C) bus, or an Institute of Electrical andElectronics Engineers (IEEE) standard 1394 bus (also referred to as“Firewire”).

The computer system 300 can share a similar computer processorarchitecture as that of a desktop computer, tablet computer, personaldigital assistant (PDA), mobile phone, game console, music player,wearable electronic device (e.g., a watch or fitness tracker),network-connected (“smart”) device (e.g., a television or home assistantdevice), virtual/augmented reality systems (e.g., a head-mounteddisplay), or another electronic device capable of executing a set ofinstructions (sequential or otherwise) that specify action(s) to betaken by the computer system 300.

While the main memory 306, non-volatile memory 310, and storage medium326 (also called a “machine-readable medium”) are shown to be a singlemedium, the term “machine-readable medium” and “storage medium” shouldbe taken to include a single medium or multiple media (e.g., acentralized/distributed database and/or associated caches and servers)that store one or more sets of instructions 328. The term“machine-readable medium” and “storage medium” shall also be taken toinclude any medium that is capable of storing, encoding, or carrying aset of instructions for execution by the computer system 300.

In general, the routines executed to implement the embodiments of thedisclosure can be implemented as part of an operating system or aspecific application, component, program, object, module, or sequence ofinstructions (collectively referred to as “computer programs”). Thecomputer programs typically include one or more instructions (e.g.,instructions 304, 308, 328) set at various times in various memory andstorage devices in a computer device. When read and executed by the oneor more processors 302, the instruction(s) cause the computer system 300to perform operations to execute elements involving the various aspectsof the disclosure.

Moreover, while embodiments have been described in the context of fullyfunctioning computer devices, those skilled in the art will appreciatethat the various embodiments are capable of being distributed as aprogram product in a variety of forms. The disclosure applies regardlessof the particular type of machine or computer-readable media used toactually effect the distribution.

Further examples of machine-readable storage media, machine-readablemedia, or computer-readable media include recordable-type media such asvolatile and non-volatile memory devices 310, floppy and other removabledisks, hard disk drives, optical discs (e.g., Compact Disc Read-OnlyMemory (CD-ROMS), Digital Versatile Discs (DVDs)), and transmission-typemedia such as digital and analog communication links.

The network adapter 312 enables the computer system 300 to mediate datain a network 314 with an entity that is external to the computer system300 through any communication protocol supported by the computer system300 and the external entity. The network adapter 312 can include anetwork adapter card, a wireless network interface card, a router, anaccess point, a wireless router, a switch, a multilayer switch, aprotocol converter, a gateway, a bridge, a bridge router, a hub, adigital media receiver, and/or a repeater.

The network adapter 312 can include a firewall that governs and/ormanages permission to access proxy data in a computer network and tracksvarying levels of trust between different machines and/or applications.The firewall can be any number of modules having any combination ofhardware and/or software components able to enforce a predetermined setof access rights between a particular set of machines and applications,machines and machines, and/or applications and applications (e.g., toregulate the flow of traffic and resource sharing between theseentities). The firewall can additionally manage and/or have access to anaccess control list that details permissions including the access andoperation rights of an object by an individual, a machine, and/or anapplication, and the circumstances under which the permission rightsstand.

FIG. 4A is a block diagram illustrating an example robotic surgicalsystem 400, in accordance with one or more embodiments. The roboticsurgical system 400 is the same as or similar to the robotic surgicalsystem 160 illustrated and described in more detail with reference toFIG. 1 . The robotic surgical system 400 can include components andfeatures discussed in connection with FIGS. 1-3 and 4B-5 . For example,the robotic surgical system 400 can include a console 420 with featuresof the console 108 of FIG. 1 . Likewise, the components and features ofFIG. 4A can be included or used with other embodiments disclosed herein.For example, the description of the input devices of FIG. 4A appliesequally to other input devices (e.g., input devices 166 of FIG. 1 ).

The robotic surgical system 400 includes a user device or console 420(“console 420”), a surgical robot 440, and a computer or data system450. The console 420 can be operated by a surgeon and can communicatewith components in an operating room 402, remote devices/servers, anetwork 404, or databases (e.g., database 106 of FIG. 1 ) via thenetwork 404. The robotic surgical system 400 can include surgicalcontrol software and can include a guidance system (e.g., ML guidancesystem, Al guidance system, etc.), surgical planning software, eventdetection software, surgical tool software, etc. or other featuresdisclosed herein to perform surgical step(s) or procedures or implementsteps of processes discussed herein.

The user 421 can use the console 420 to view and control the surgicalrobot 440. The console 420 can be communicatively coupled to one or morecomponents disclosed herein and can include input devices operated byone, two, or more users. The input devices can be hand-operatedcontrols, but can alternatively, or in addition, include controls thatcan be operated by other parts of the user's body, such as, but notlimited to, foot pedals. The console 420 can include a clutch pedal toallow the user 421 to disengage one or more sensor-actuator componentsfrom control by the surgical robot 440. The console 420 can also includedisplay or output so that the one or more users can observe the patientbeing operated on, or the product being assembled, for example. In someembodiments, the display can show images, such as, but not limited tomedical images, video, etc. For surgical applications, the images couldinclude, but are not limited to, real-time optical images, real-timeultrasound, real-time OCT images and/or other modalities, or couldinclude preoperative images, such as MRI, CT, PET, etc. The variousimaging modalities can be selectable, programmed, superimposed and/orcan include other information superimposed in graphical and/or numericalor symbolic form.

The robotic surgical system 400 can include multiple consoles 420 toallow multiple users to simultaneously or sequentially perform portionsof a surgical procedure. The term “simultaneous” herein refers toactions performed at the same time or in the same surgical step. Thenumber and configuration of consoles 420 can be selected based on thesurgical procedure to be performed, number and configurations ofsurgical robots, surgical team capabilities, or the like.

FIG. 4B illustrates an example console 420 of the robotic surgicalsystem 400 of FIG. 4A, in accordance with one or more embodiments. Theconsole 420 includes hand-operated input devices 424, 426, illustratedheld by the user's left and right hands 427, 428, respectively. A viewer430 includes left and right eye displays 434, 436. The user can view,for example, the surgical site, instruments 437, 438, or the like. Theuser's movements of the input devices 424, 426 can be translated inreal-time to, for example, mimic the movement of the user on the viewer430 and display (e.g., display 124 of FIG. 1 ) and within the patient'sbody while the user can be provided with output, such as alerts,notifications, and information. The information can include, withoutlimitation, surgical or implantation plans, patient vitals, modificationto surgical plans, values, scores, predictions, simulations, and otheroutput, data, and information disclosed herein. The console 420 can belocated at the surgical room or at a remote location.

The viewer 430 can display at least a portion of a surgical plan,including past and future surgical steps, patient monitor readings(e.g., vitals), surgical room information (e.g., available team members,available surgical equipment, surgical robot status, or the like),images (e.g., pre-operative images, images from simulations, real-timeimages, instructional images, etc.), and other surgical assistinformation. In some embodiments, the viewer 430 can be a VR/AR headset,display, or the like. The robotic surgical system 400, illustrated anddescribed in more detail with reference to FIG. 4A, can further includemultiple viewers 430 so that multiple members of a surgical team canview the surgical procedure. The number and configuration of the viewers430 can be selected based on the configuration and number of surgicalrobots.

Referring again to FIG. 4A, the surgical robot 440 can include one ormore controllers, computers, sensors, arms, articulators, joints, links,grippers, motors, actuators, imaging systems, effector interfaces, endeffectors, or the like. For example, a surgical robot with a high numberof degrees of freedom can be used to perform complicated procedureswhereas a surgical robot with a low number of degrees of freedom can beused to perform simple procedures. The configuration (e.g., number ofarms, articulators, degrees of freedom, etc.) and functionality of thesurgical robot 440 can be selected based on the procedures to beperformed.

The surgical robot 440 can operate in different modes selected by auser, set by the surgical plan, and/or selected by the robotic surgicalsystem 400. In some procedures, the surgical robot 440 can remain in thesame mode throughout a surgical procedure. In other procedures, thesurgical robot 440 can be switched between modes any number of times.The configuration, functionality, number of modes, and type of modes canbe selected based on the desired functionality and user control of therobotic surgical system 400. The robotic surgical system 400 can switchbetween modes based on one or more features, such as triggers,notifications, warnings, events, etc. Different example modes arediscussed below. A trigger can be implemented in software to execute ajump to a particular instruction or step of a program. A trigger can beimplemented in hardware, e.g., by applying a pulse to a trigger circuit.

In a user control mode, a user 421 controls, via the console 420,movement of the surgical robot 440. The user's movements of the inputdevices can be translated in real-time into movement of end effectors452 (one identified).

In a semi-autonomous mode, the user 421 controls selected steps and thesurgical robot 440 autonomously performs other steps. For example, theuser 421 can control one robotic arm to perform one surgical step whilethe surgical robot 440 autonomously controls one or more of the otherarms to concurrently perform another surgical step. In another example,the user 421 can perform steps suitable for physician control. Aftercompletion, the surgical robot 440 can perform steps involvingcoordination between three or more robotic arms, thereby enablingcomplicated procedures. For example, the surgical robot 440 can performsteps involving four or five surgical arms, each with one or more endeffectors 452.

In an autonomous mode, the surgical robot 440 can autonomously performsteps under the control of the data system 450. The robotic surgicalsystem 400 can be pre-programmed with instructions for performing thesteps autonomously. For example, command instructions can be generatedbased on a surgical plan. The surgical robot 440 autonomously performssteps or the entire procedure. The user 421 and surgical team canobserve the surgical procedure to modify or stop the procedure.Advantageously, complicated procedures can be autonomously performedwithout user intervention to enable the surgical team to focus andattend to other tasks. Although the robotic surgical system 400 canautonomously perform steps, the surgical team can provide information inreal-time that is used to continue the surgical procedure. Theinformation can include physician input, surgical team observations, andother data input.

The robotic surgical system 400 can also adapt to the user control tofacilitate completion of the surgical procedure. In some embodiments,the robotic surgical system 400 can monitor, via one or more sensors, atleast a portion of the surgical procedure performed by the surgicalrobot 440. The robotic surgical system 400 can identify an event, suchas a potential adverse surgical event, associated with a roboticallyperformed surgical task. For example, a potential adverse surgical eventcan be determined based on acquired monitoring data and information forthe end effector, such as surgical tool data from a medical devicereport, database, manufacturer, etc. The robotic surgical system 400 canperform one or more actions based on the identified event. The actionscan include, without limitation, modification of the surgical plan toaddress the potential adverse surgical event, thereby reducing the riskof the event occurring.

In some embodiments, the robotic surgical system 400 can determinewhether a detected event is potentially an adverse surgical event basedon one or more criteria set by the robotic surgical system 400, user, orboth. The adverse surgical event can be an adverse physiological eventof the patient, surgical robotic malfunction, surgical errors, or otherevent that can adversely affect the patient or the outcome of thesurgery. Surgical events can be defined and inputted by the user,surgical team, healthcare provider, manufacturer of the robotic surgerysystem, or the like.

The robotic surgical system 400 can take other actions in response toidentification of an event. If the robotic surgical system 400identifies an end effector malfunction or error, the robotic surgicalsystem 400 can stop usage of the end effector and replace themalfunctioning component (e.g., surgical tool or equipment) to completethe procedure. The robotic surgical system 400 can monitor hospital oron-site inventory, available resources in the surgical room 402, time toacquire equipment (e.g., time to acquire replacement end effectors,surgical tools, or other equipment), and other information to determinehow to proceed with surgery. The robotic surgical system 400 cangenerate multiple proposed surgical plans for continuing with thesurgical procedure. The user and surgical team can review the proposedsurgical plans to select an appropriate surgical plan. The roboticsurgical system 400 can modify a surgical plan with one or morecorrective surgical steps based on identified surgical complications,sensor readings, or the like.

The robotic surgical system 400 can retrieve surgical system informationfrom a database to identify events. The database can describe, forexample, maintenance of the robotic surgery system, specifications ofthe robotic surgery system, specifications of end effectors, surgicalprocedure information for surgical tools, consumable informationassociated with surgical tools, operational programs and parameters forsurgical tools, monitoring protocols for surgical tools, or the like.The robotic surgical system 400 can use other information in databasesdisclosed herein to generate rules for triggering actions, identifyingwarnings, defining events, or the like. Databases can be updated withdata (e.g., intraoperative data collected during the surgical procedure,simulation data, etc.) to intraoperatively adjust surgical plans,collect data for ML/AI training sets, or the like. Data from on-site andoff-site simulations (e.g., pre- or post-operative virtual simulations,simulations using models, etc.) can be generated and collected.

The surgical robot 440 can include robotic arms 451 (one identified)with integrated or removable end effectors 452 (one identified). The endeffectors 452 can include, without limitation, imagers (e.g., cameras,optical guides, etc.), robotic grippers, instrument holders, cuttinginstruments (e.g., cutters, scalpels, or the like), drills, cannulas,reamers, rongeurs, scissors, clamps, or other equipment or surgicaltools disclosed herein. In some embodiments, the end effectors can bereusable or disposable surgical tools. The number and configuration ofend effectors can be selected based on the configuration of the roboticsystem, procedure to be performed, surgical plan, etc. Imaging andviewing technologies can integrate with the surgical robot 440 toprovide more intelligent and intuitive results.

The data system 450 can improve surgical planning, monitoring (e.g., viathe display 422), data collection, surgical robotics/navigation systems,intelligence for selecting instruments, implants, etc. The data system450 can execute, for example, surgical control instructions or programsfor a guidance system (e.g., ML guidance system, Al guidance system,etc.), surgical planning programs, event detection programs, surgicaltool programs, etc. For example, the data system 450 can increaseprocedure efficiency and reduce surgery duration by providinginformation insertion paths, surgical steps, or the like. The datasystem 450 can be incorporated into or include other components andsystems disclosed herein.

The robotic surgical system 400 can be used to perform open procedures,minimally invasive procedures, such as laparoscopic surgeries,non-robotic laparoscopic/abdominal surgery, retroperitoneoscopy,arthroscopy, pelviscopy, nephroscopy, cystoscopy, cisternoscopy,sinoscopy, hysteroscopy, urethroscopy, and the like. The methods,components, apparatuses, and systems can be used with many differentsystems for conducting robotic or minimally invasive surgery. Oneexample of a surgical system and surgical robots which can incorporatemethods and technology is the DAVINCI™ system available from IntuitiveSurgical, Inc.™ of Mountain View, Calif. However, other surgicalsystems, robots, and apparatuses can be used.

The robotic surgical system 400 can perform one or more simulationsusing selected entry port placements and/or robot positions, to allow asurgeon or other user to practice procedures. The practice session canbe used to generate, modify, or select a surgical plan. In someembodiments, the system can generate a set of surgical plans forphysician consideration. The physician can perform practice sessions foreach surgical plan to determine and select a surgical plan to beimplemented. In some embodiments, the systems disclosed herein canperform virtual surgeries to recommend a surgical plan. The physiciancan review the virtual simulations to accept or reject the recommendedsurgical plan. The physician can modify surgical plans pre-operativelyor intraoperatively. Kits (e.g., pre-operative kits, intraoperativekits, etc.) can be modified or provided based on the modification.

Embodiments can provide a means for mapping the surgical path forneurosurgery procedures that minimize damage through artificialintelligence mapping. The software for artificial intelligence istrained to track the least destructive pathway. The physician can makean initial incision based on a laser marking on the skin thatilluminates an optimal site. Next, a robot can make a small hole andinsert surgical equipment (e.g., guide wires, cannulas, etc.) thathighlights the best pathway. This pathway minimizes the amount of tissuedamage that occurs during surgery. Mapping can also be used to identifyone or more insertion points associated with a surgical path. Mappingcan be performed before treatment, during treatment, and/or aftertreatment. For example, pretreatment and posttreatment mapping can becompared by the surgeon and/or ML/AI system. The comparison can be usedto determine next steps in a procedure and/or further train the ML/AIsystem.

FIG. 5 is a schematic block diagram illustrating subcomponents of therobotic surgical system 400 of FIG. 4A in accordance with embodiment ofthe present technology. The data system 450 has one or more processors504, a memory 506, input/output devices 508, and/or subsystems and othercomponents 510. The processor 504 can perform any of a wide variety ofcomputing processing, image processing, robotic system control, plangeneration or modification, and/or other functions. Components of thedata system 450 can be housed in a single unit (e.g., within a hospitalor surgical room) or distributed over multiple, interconnected units(e.g., though a communications network). The components of the datasystem 450 can accordingly include local and/or devices.

As illustrated in FIG. 5 , the processor 504 can include a plurality offunctional modules 512, such as software modules, for execution by theprocessor 504. The various implementations of source code (i.e., in aconventional programming language) can be stored on a computer-readablestorage medium or can be embodied on a transmission medium in a carrierwave. The modules 512 of the processor 504 can include an input module514, a database module 516, a process module 518, an output module 520,and, optionally, a display module 524 for controlling the display.

In operation, the input module 514 accepts an operator input 524 via theone or more input devices, and communicates the accepted information orselections to other components for further processing. The databasemodule 516 organizes plans (e.g., robotic control plans, surgical plans,etc.), records (e.g., maintenance records, patient records, historicaltreatment data, etc.), surgical equipment data (e.g., instrumentspecifications), control programs, and operating records and otheroperator activities, and facilitates storing and retrieving of theserecords to and from a data storage device (e.g., internal memory 506,external databases, etc.). Any type of database organization can beutilized, including a flat file system, hierarchical database,relational database, distributed database, etc.

In the illustrated example, the process module 518 can generate controlvariables based on sensor readings 526 from sensors (e.g., end effectorsensors of the surgical robot 440, patient monitoring equipment, etc.),operator input 524 (e.g., input from the surgeon console 420 and/orother data sources), and the output module 520 can communicate operatorinput to external computing devices and control variables tocontrollers. The display module 522 can be configured to convert andtransmit processing parameters, sensor readings 526, output signals 528,input data, treatment profiles and prescribed operational parametersthrough one or more connected display devices, such as a display screen,touchscreen, printer, speaker system, etc.

In various embodiments, the processor 504 can be a standard centralprocessing unit or a secure processor. Secure processors can bespecial-purpose processors (e.g., reduced instruction set processor)that can withstand sophisticated attacks that attempt to extract data orprogramming logic. The secure processors cannot have debugging pins thatenable an external debugger to monitor the secure processor's executionor registers. In other embodiments, the system can employ a secure fieldprogrammable gate array, a smartcard, or other secure devices.

The memory 506 can be standard memory, secure memory, or a combinationof both memory types. By employing a secure processor and/or securememory, the system can ensure that data and instructions are both highlysecure and sensitive operations such as decryption are shielded fromobservation. In various embodiments, the memory 506 can be flash memory,secure serial EEPROM, secure field programmable gate array, or secureapplication-specific integrated circuit. The memory 506 can storeinstructions for causing the surgical robot 440 to perform actsdisclosed herein.

The input/output device 508 can include, without limitation, atouchscreen, a keyboard, a mouse, a stylus, a push button, a switch, apotentiometer, a scanner, an audio component such as a microphone, orany other device suitable for accepting user input and can also includeone or more video monitors, a medium reader, an audio device such as aspeaker, any combination thereof, and any other device or devicessuitable for providing user feedback. For example, if an applicatormoves an undesirable amount during a treatment session, the input/outputdevice 508 can alert the subject and/or operator via an audible alarm.The input/output device 508 can be a touch screen that functions as bothan input device and an output device.

The data system 450 can output instructions to command the surgicalrobot 440 and communicate with one or more databases 500. The surgicalrobot 440 or other components disclosed herein can communicate to sendcollected data (e.g., sensor readings, instrument data, surgical robotdata, etc.) to the database 500. This information can be used to, forexample, create new training data sets, generate plans, perform futuresimulations, post-operatively analyze surgical procedures, or the like.The data system 450 can be incorporated, used with, or otherwiseinteract with other databases, systems, and components disclosed herein.In some embodiments, the data system 450 can be incorporated into thesurgical robot 440 or other systems disclosed herein. In someembodiments, the data system 450 can be located at a remote location andcan communicate with a surgical robot via one or more networks. Forexample, the data system 450 can communicate with a hospital via anetwork, such as a wide area network, a cellular network, etc. One ormore local networks at the hospital can establish communication channelsbetween surgical equipment within the surgical room.

A surgical program or plan (“surgical plan”) can include, withoutlimitation, patient data (e.g., pre-operative images, medical history,physician notes, etc.), imaging programs, surgical steps, mode switchingprograms, criteria, goals, or the like. The imaging programs caninclude, without limitation, AR/VR programs, identification programs(e.g., fiducial identification programs, tissue identification programs,target tissue identification programs, etc.), image analysis programs,or the like. Surgical programs can define surgical procedures or aportion thereof. For example, surgical programs can include end effectorinformation, positional information, surgical procedure protocols,safety settings, surgical robot information (e.g., specifications, usagehistory, maintenance records, performance ratings, etc.), order ofsurgical steps, acts for a surgical step, feedback (e.g., hapticfeedback, audible feedback, etc.), or the like. The mode switchingprograms can be used to determine when to switch the mode of operationof the surgical robot 440. For example, mode switching programs caninclude threshold or configuration settings for determining when toswitch the mode of operation of the surgical robot 440. Example criteriacan include, without limitation, thresholds for identifying events, datafor evaluating surgical steps, monitoring criteria, patient healthcriteria, physician preference, or the like. The goals can includeintraoperative goals, post-operative goals (e.g., target outcomes,metrics, etc.), goal rankings, etc. Monitoring equipment or the surgicalteam can determine goal progress, whether a goal has been achieved, etc.If an intraoperative goal is not met, the surgical plan can be modifiedin real-time so that, for example, the post-operative goal is achieved.The post-operative goal can be redefined intraoperatively in response toevents, such as surgical complications, unplanned changes to patient'svitals, etc.

The surgical plan can also include healthcare information, surgical teaminformation, assignments for surgical team members, or the like. Thehealthcare information can include surgical room resources, hospitalresources (e.g., blood banks, standby services, available specialists,etc.), local or remote consultant availability, insurance information,cost information (e.g., surgical room costs, surgical team costs, etc.).

The systems disclosed herein can generate pre-operative plans andsimulation plans. Pre-operative plans can include scheduling ofequipment, surgical room, staff, surgical teams, and resources forsurgery. The systems can retrieve information from one or more databasesto generate the pre-operative plan based on physician input, insuranceinformation, regulatory information, reimbursements, patient medicalhistory, patient data, or the like. Pre-operative plans can be used togenerate surgical plans, cost estimates, scheduling of consultants andremote resources, or the like. For example, a surgical plan can begenerated based on available resources scheduled by the pre-operativeplans. If a resource becomes unavailable, the surgical plan can beadjusted for the change in resources. The healthcare provider can bealerted if additional resources are recommended. The systems disclosedherein can generate simulation plans for practicing surgical procedures.On approval, a surgeon can virtually simulate a procedure using aconsole or another simulation device. Plans (e.g., surgical plans,implantation plans, etc.) can be generated and modified based on thesurgeon's performance and simulated outcome.

The systems disclosed herein can generate post-operative plans forevaluating surgical outcomes, developing physical therapy and/or rehabprograms and plans, etc. The post-operative plans can be modified by thesurgical team, primary care provider, and others based on the recoveryof the patient. In some embodiments, systems generate pre-operativeplans, surgical plans, and post-operative plans prior to beginning asurgical procedure. The system then modifies one or more or the plans asadditional information is provided. For example, one or more steps ofthe methods discussed herein can generate data that is incorporated intothe plan. ML data sets to be incorporated into the plan generate a widerange of variables to be considered when generating plans. Plans can begenerated to improve patient outcome, reduce or limit the risk ofsurgical complications, mitigate adverse events, manage costs forsurgical procedures, reduce recovery time, or the like. The healthcareprovider can modify how plans are generated over time to furtheroptimize based on one or more criteria.

FIG. 6 is a block diagram illustrating an example robotic surgicalsystem for customized kit assembly for surgical implants, in accordancewith one or more embodiments. The implantation of surgical implants orsurgical implant components is sometimes referred to as “insertion” or“installation.” Surgical implants are sometimes referred to as“implants.” Surgical implant components are sometimes referred to as“implant components.” The system of FIG. 6 includes at least onesurgical robot 602 a, databases and modules that can be implemented inthe cloud 620, and at least one surgical implant 616. The surgical robot602 is the same as or similar to the surgical robot 440 illustrated anddescribed in more detail with reference to FIG. 4A. The system isimplemented using the components of the example computer system 300illustrated and described in more detail with reference to FIG. 3 .Likewise, embodiments of the system can include different and/oradditional components or can be connected in different ways.

The robotic surgical system of FIG. 6 includes a surgical robot 602,which is a robotic system designed to assist a surgeon in performing asurgical operation on a patient. The surgical robot 602 includes atleast one controller 610 and at least one robotic arm 604 having an endeffector 606 or an imaging device 614. The controller 610 is implementedusing the components of the example computer system 300 illustrated anddescribed in more detail with reference to FIG. 3 . The surgical robot602 further includes a user interface 608 for accepting control inputsfrom a user, such as a surgeon or other medical professional, and acommunications interface 612 for transmitting and receiving data to andfrom a cloud 620 for the purpose of training an artificial intelligence(Al) operating within the surgical robot 602 or receiving remotecommands from a remote user or an Al (see FIG. 2 ) implemented externalto the surgical robot 602. The robotic arm 604 is a mechanicallyactuated arm or lever with at least two degrees of freedom. The roboticarm 604 typically includes at least one end effector 606 or an imagingdevice 614 and may include both the end effector 606 and the imagingdevice 614. The robotic arm 604 can additionally be capable of changingthe end effector 606 to facilitate multiple functions and operation of avariety of tools. Example surgical tools 154 are illustrated anddescribed in more detail with reference to FIG. 1 .

The robotic arm 604 can be manually controlled or operated in anautonomous or semi-autonomous mode. The surgical robot 602 can have onerobotic arm 604 or multiple robotic arms 604, each of which can beoperated independently by one or more users or autonomous systems or acombination of users and autonomous systems. The end effector 606 is theend of the robotic arm 604 that is conducting work. The end effector 606is typically a tool or device for interacting with a physical object andcan be a surgical tool 154 intended for acting upon or within a patientor can be a gripping device for securing a separate surgical tool 154 tothe robotic arm 604. The end effector 606 can be permanently affixed tothe end of the robotic arm 604 or can be detachable allowing for asystem of interchangeable end effectors 606, which can alternatively beselected and swapped by the robotic arm 604 or multiple robotic arms.

The user interface 608 is a means of interacting with the surgical robot602 and can include any of a keyboard, computer mouse, trackball,joystick, wireless or wired gamepad, sliders, scroll wheels, touchscreen or microphone for receiving voice commands. The user interfacecan additionally perform other methods of interaction of a user with thesurgical robot 602. The user interface 608 can accept direct inputs,such as from a joystick controlling the movement of the robotic arm 604or indirect inputs such as commands entered on a keyboard or touchscreen such as adjusting the sensitivity of a joystick control or thespeed of the robotic arm 104's movement in response to a joystick. Thecontroller 610 is a computing device including a processor forcompleting computations and a memory component for storing data for usein computations. The memory can store data temporarily such as forintermediate values used by the controller 610 to complete complexcomputations or can include persistent storage for longer term storageof information. The controller 610 is in communication with thecommunications interface 612 and can further be allowed to control theat least one robotic arm 604 and end effector 606 of the surgical robot602.

The communications interface 612 allows the surgical robot 602 tocommunicate with external devices and can include a wireless antenna andtransceiver or a port for receiving a cable to facilitate a wiredconnection. Examples of a wired connection include ethernet, universalserial bus (USB) or a proprietary connection. A wireless communicationsinterface can include any of WiFi, Bluetooth, near field communications(NFC) or a cellular communications interface such as 3G, 4G, LTE, or 5G.The communications interface 612 can connect a user interface to thesurgical robot 602 or can facilitate access to a local network or thecloud 620's network to access a remote server and/or database.

In some embodiments, the one or more imaging devices 614 of the surgicalsystem of FIG. 6 generate images of a portion of a particular patient'sanatomy or body for implanting the surgical implant 616 in theparticular patient's anatomy or body for a particular treatment ormedical application. The imaging device 614 is any device capable ofdetecting sound or electromagnetic waves and assembling a visualrepresentation of the detected waves. The imaging devices 614 cancollect waves from any part of the electromagnetic spectrum or sounds atany range of frequencies, often as a matrix of independently acquiredmeasurements which each represent a pixel of a two or three-dimensionalimage. These measurements can be taken simultaneously or in series via ascanning process or a combination of methods. Some pixels of an imageproduced by an imaging device can be interpolated from directmeasurements representing adjacent pixels in order to increase theresolution of a generated image.

The imaging devices 614 can receive or generate imaging data frommultiple devices. The multiple devices can include, for example, camerasattached to the robotic arm 604, cameras mounted to the ceiling or otherabove the surgical theater, cameras that can be mounted on a tripod orother independent mounting device, cameras that can be body worn by thesurgeon or other surgical staff, cameras that can be incorporated into awearable device, such as an augmented reality device such as GoogleGlass™, cameras that can be integrated to an endoscopic, microscopic,laparoscopic, or any camera or other imaging device (e.g., ultrasound)that can be present in the surgical theater. The imaging device 614 caninclude any algorithm or software module capable of determiningqualitative or quantitative data from medical images, which can be, forexample, a deep learning algorithm that has been trained on a data setof medical images (see FIG. 2 ). The implant 616 is a therapeuticprosthetic device intended to reinforce or restore functionality to apart of a body which has been impacted by an injury, typicallytraumatic, or a degenerative disease which can result in the loss ordestruction of a part of the body.

The surgical implants 616 can be rigid, such as when reinforcing bonestructures, or can be flexible, such as when replacing or supplementingsoft tissues. Similarly, the surgical implant 616 can be static andunmoving, or can include articulating joints or other moveable elements.The surgical implant 616 can include any of a range of materials, eachof which can have different properties such as being rigid or flexible.Multiple materials can be utilized in the different surgical implantcomponents 618 or where the surgical implant components 618 meet toperform different functions, creating more complex implants. The implantcomponents 618 a are generic, off-the-shelf implant components while theimplant components 618 b are implant components that can be or have beenmodified or customized for a particular patient using the embodimentdescribed herein. The surgical implant 616 can be a single piece or caninclude multiple surgical implant components 618. Surgical implants thatinclude multiple implant components 618 can alternatively be referred toas assemblies. The implants 616 can be customized to fit a particularpatient or a specific application that the implant 616 is intended for.For example, the implant 616 can include biological donor tissues orbiosynthetic tissues such as can be used in operations such as organtransplant, skin graft, or other tissue installation or replacement. Inother examples, the implant 616 can be any of multiple implantablemedical devices, e.g., cardiac pacemakers, electric neurologicalstimulation devices such as vagus nerve stimulators or deep brainstimulators, blood glucose monitors, insulin pumps, etc.

The implant component 618 is a single manufacturable component of animplant. The implant component 618 can include subassemblies such ashinges, balls, and sockets to create joints or simple components such asscrews, rods, plates, and other components which can be included in theimplant 616. The implant components 618 b can be customized when theyare manufactured, or alternatively, before or during implantation. Thecloud 620 is a distributed network of computers comprising servers anddatabases. The cloud 620 can be a private cloud, where access isrestricted by isolating the network such as preventing external access,or by using encryption to limit access to only authorized users.Alternatively, the cloud 620 can be a public cloud where access iswidely available via the internet. A public cloud may not be secured orcan be include limited security features. A historical treatmentdatabase or implant database 622 stores data from previously installedimplants. The data describes the design and implantation of the previousimplants, the tool paths used during the previous implantationprocedures, and previous patient information such as gender, age,height, weight, medical conditions, allergies, or vital information suchas baseline measurements of heart rate, blood pressure, blood oxygensaturation, or respiration rate.

The implant database 622 is sometimes referred to as a historicaltreatment database. The implant database 622 is populated with data fromthe assembly module 624, medical professionals such as surgeons,physicians, nurses, or physical therapists, or from surveys of previouspatient outcomes to evaluate the success of the previous implants. Theimplant database 622 can be used by the planning module 626 oroptimization module 628 to determine a customized implant design,placement, or tool paths for inserting the implant 616 and furthercustomizing the implant components 618 b or enabling the creation of acustomized kit assembly of implant components 618 b. The assembly module624 designs the implant 616 for a particular patient and the implantcomponents 618 b are assembled into a kit which can be used by a surgeonto insert the implant 616 in the patient for whom it was designed. Thedesign process additionally includes the placement of the implantcomponents 618 and the tool paths to be used to insert the implant 616as well as implantation parameters used during the implantation process.The assembly module 624 triggers the planning module 626 to generate animplantation plan, triggers the optimization module to further customizeeach implant component 618 b for the patient, and further selects anappropriate part from available generic parts or determines that acustom implant component 618 is needed.

In some embodiments, one or more processors generate an implantationplan comprising implantation parameters for controlling insertion of thecustomized version of the surgical implant 616 into a particularpatient's body by the surgical robot 602 of the surgical system of FIG.6 . For example, the planning module 626 images the patient using atleast one imaging device 614 and generates the implantation plan. Theimplantation plan includes a design of the implant 616 and implantplacement within a virtual model of a portion of a patient's anatomy orbody generated from the images acquired of the patient. The planningmodule 626 further generates tool paths and implantation parameters tobe used during insertion of the implant 616. The optimization module 628receives information describing an initial implant component 618 a fromthe assembly module 624. The information can be generated by theplanning module 622.

In some embodiments, one or more processors of the surgical system ofFIG. 6 design a customized version of the surgical implant 616 usingpatient data describing a particular patient's anatomy or body, atreatment or particular medical application, and the implant database622. The customized version of the surgical implant 616 comprises atleast the generic surgical implant component 618 a and the customizedsurgical implant component 618 b. The customized surgical implantcomponent 618 b is for the particular patient and the treatment orparticular medical application. For example, the optimization module 628uses data from the implant database 622 to customize the implantcomponent 618 b to the patient. An inventory database 630 stores datadescribing a stock of generic implant components 618 a. The implantcomponents 618 a can include any of screws, rods, plates, orcommercially available implant components. In some embodiments, one ormore processors of the system of FIG. 6 determine absence of thecustomized surgical implant component 618 b in an inventory. The one ormore processors cause manufacture of the customized surgical implantcomponent 618 b in response to determining the absence in the inventory.For example, the inventory database 630 can additionally includemanufacturing capabilities to determine whether an implant component 618can be manufactured. The inventory database 630 can additionally includedata on third party vendors including manufacturing capabilities andinformation necessary to order a custom implant component 618 b. Theinventory database 630 can include information about tools, instruments,and other equipment associated with surgical procedures.

In some embodiments, a path is generated for a surgical tool 154 in avirtual model of the patient's anatomy or body to virtually insert thecustomized version of the surgical implant 616 in the virtual model. Avirtual robotic surgical procedure is performed according to theimplantation plan to virtually insert a model of the customized versionof the surgical implant 616 at an implantation site. One or moresurgical steps of the implantation plan are simulated using athree-dimensional (3D) model generated using real-time patient data. The3D model is analyzed in the virtual simulation to determine theimplantation parameters. It is determined whether a surgical step of theimplantation plan should be performed robotically or by a physician. Avirtual simulation is generated using prior patient data for similarsurgical procedures. A surgical step is repeatedly simulated usingdifferent tool paths and implantation parameters until a simulatedsurgical step meets approval criteria. Patient data is received uponcompletion of a surgical step. The patient data is captured by animaging device 614 in real-time.

FIG. 7 is a table illustrating an example surgical implant database 622,in accordance with one or more embodiments. The implant database 622 issometimes referred to as a historical treatment database. The implantdatabase 622 (see FIG. 6 ) stores data from previously insertedimplants. In some embodiments, the implant database 622 comprisesinformation describing previously inserted surgical implants. Theinformation comprises at least one of designs of the previously insertedsurgical implants, components of the previously inserted surgicalimplants, surgical tool paths for the previously inserted surgicalimplants, or operational parameters of surgical tools for the previouslyinserted surgical implants. The data includes the designs and placementof previous implants, previous tool paths used during implantationprocedures, and previous patient information such as gender, age,height, weight, medical conditions, patient medical history, patientfamily medical history, allergies, or vital information such as baselinemeasurements of heart rage, blood pressure, blood oxygen saturation, orrespiration rate.

The implant database 622 is populated with data from the assembly module624, medical professionals such as surgeons, physicians, nurses, orphysical therapists, or from surveys of previous patient outcomes toevaluate the success of the previous implants. The implant database 622is used by the planning module 626 or the optimization module 628 todetermine an improved implant design, placement, and tool paths forinserting the implant 616. In some embodiments, the surgical robot 602assembles the generic surgical implant component 618 a and thecustomized surgical implant component 618 b into a kit for inserting thecustomized version of the surgical implant 616 into a particularpatient's body. For example, the implant database 622 is used by theplanning module 626 or the optimization module 628 to further customizethe implant components 618 b and generate a kit of implant components618 to be used during implantation of the implant 616.

FIG. 8 is a flow diagram illustrating an example process for customizedkit assembly for surgical implants, in accordance with one or moreembodiments. In some embodiments, the process of FIG. 8 is performed bythe assembly module 624. The assembly module 624 is illustrated anddescribed in more detail with reference to FIG. 6 . In otherembodiments, the process of FIG. 8 is performed by a computer system,e.g., the example computer system 300 illustrated and described in moredetail with reference to FIG. 3 . Particular entities, for example, theconsole 108 or the robotic surgical system 160 perform some or all ofthe steps of the process in other embodiments. The console 108 and therobotic surgical system 160 are illustrated and described in more detailwith reference to FIG. 1 . Likewise, embodiments can include differentand/or additional steps, or perform the steps in different orders.

In step 802, the assembly module 624 receives patient data such asgender, age, height, weight, allergies, current or prior medicalconditions, or any additional clinical information that can impact theoutcome of the surgical procedure. The assembly module 624 furtheracquires vital information such as the patient's blood pressure, heartrate, blood oxygen saturation, respiration rate, etc. Baseline vitalinformation can be accessed from the clinical information or measureddirectly. For example, the patient data indicates that the patient is a57-year-old female who is 66 inches tall and weighs 160 pounds, isallergic to latex and has an osteoporosis diagnosis. The patient datafurther includes baseline vitals such as a heart rate of 65 beats perminute, blood pressure of 145/105, blood oxygen saturation of 99, andrespirations of 6 breaths per minute.

In step 804, the assembly module 624 triggers the planning module 626(see FIG. 6 ) to generate an implantation plan for the design,placement, and insertion of the implant 616. The insertion of theimplant 616 can be performed manually by a surgeon, with the assistanceof the surgical robot 602, or autonomously by one or more surgicalrobots. Alternatively, the implant 616 can be installed in part by asurgeon, and in part by the surgical robot 602 working autonomously. Asurgeon and the surgical robot 602 can further perform actions in asynchronized manner. The planning module 626 generates a virtual modelof a portion of the patient's anatomy or body, selects the implantcomponents 618, places models of the implant components 618 in thevirtual model, and selects tool paths and implantation parameters tofacilitate insertion of the implant 616.

In step 806, the assembly module 624 receives the implantation plan fromthe planning module 626. The implantation plan specifies at least oneimplant 616 that includes at least one implant component 618 a, theplacement of models of the implant components 618 in a virtual model ofthe patient, and the paths that surgical tools 154 (see FIG. 1 ) and theimplant components 618 will take within the body of the patient during asurgical procedure to insert the implant 616. For example, the implantcomponents 618 include 6 screws, each having a tulip head, two rods, andtwo plates, each made of titanium. The 6 screws are to be inserted 1inch each into three vertebrae, one screw on either side of the spinousprocess on each vertebra.

In step 808, the assembly module 624 selects an implant component 618 aor 618 b from the implant components 618 specified in the implantationplan. For example, the implant component 618 a is a screw with a tuliphead. In another example, the implant component 618 a is a rod. Inanother example, the implant component 618 a is a plate. In a furtherexample, the implant component 618 b is a customized volume or bracket.

In step 810, the assembly module 624 triggers the optimization module628, which receives information describing the implant component 618 aand placement data. The optimization module 628 further receives toolpaths and implantation parameters to be used when inserting the implantcomponent 618 a. The optimization module 628 retrieves patient data andutilizes data from the implant database 622 to determine the bestmaterials and physical features for the implant component 618 a for thepatient. For example, the optimization module 628 receives informationspecifying a screw having a tulip head intended to be installed 1 inchleft of the spinous process of the T6 vertebra as part of the implant616 to complete a fusion 360 procedure.

In step 812, the assembly module 624 receives information describing acustomized implant component 618 b from the optimization module 628. Theimplant component 618 b can be modified by the optimization module 628using patient data and data from previously inserted implants 616 fromthe implant database 622 to better accommodate the patient's physiologyincluding allergies and medical conditions. For example, a patient hasosteoporosis and therefore a screw meant to be used in the implant 616is elongated from 1 inch to 1.5 inches and the threads per inch arereduced from 24 to 18. The screw can further be modified by adjusting agage, length, size or shape of the head, type of head, or the pitch,thread angle, minor diameter, or major diameter of the threads.Similarly, the material can be changed from surgical stainless steel totitanium or a titanium alloy. Similarly, a rod or plate can be alteredby adding or changing a bend in the rod or plate. The rod can further bemodified with a complex curve or a plate can be modified with a morecomplex geometry or replaced by a volume.

In step 814, the assembly module 624 queries the inventory database 630for a stock of generic or otherwise in-stock implant components 618 a.In an embodiment, the in-stock generic implant components 618 a includescrews of various sizes ranging from 0.5 inches to 3 inches having arange of standard and metric threads with tulip heads and traditionalrounded star heads. The screws can alternatively be comprised ofproprietary designs. The inventory database 630 can additionally includean inventory of rods and plates. The rods can be available in a range ofdiameters and lengths and the plates can similarly be available in arange of dimensions and can have holes and other features to acceptscrews and other hardware. The implant components 618 a can additionallybe available in a range of materials such as surgical stainless steeland titanium or alloys. The inventory database 630 can also contain themanufacturing capabilities and order information for third party vendorsin order to enable ordering of custom implant components 618 b fromthird party sources.

In step 816, the assembly module 624 determines whether the customizedimplant component 618 b matches an implant component 618 a in stockaccording to the inventory database 630. A matching implant component618 a can be an exact match or can match required design parameterswhile not necessarily matching optional design parameters. For example,the customized implant component 618 b is a 1.5-inch titanium screwhaving 18 threads per inch and a tulip head. The assembly module 624determines that the screw is immediately available as indicated by aquantity of 5 returned by the inventory database 630. Alternatively, thematerial is optional and the screw is available in stainless steel;therefore, the assembly module 624 selects the stainless steelalternative as a matching generic component. In another example, thetitanium material is not optional, and therefore a generic component isnot available.

In step 818, the assembly module 624 determines whether a custom implantcan be manufactured on-site by retrieving the manufacturing capabilitiesfor the present site from the inventory database 630 and comparing themanufacturing capabilities to the process required to manufacture theimplant component 618 b. For example, the implant component 618 b is ascrew and requires casting. In step 818, the assembly module 624determines that casting is not available on site and therefore thecustom implant component 618 b cannot be manufactured on site.Alternatively, the assembly module 624 determines that the screw can bemachined and that a 5-axis CNC mill is available on site and thereforethe implant component 618 b can be manufactured on site.

In step 820, the assembly module 624 enables manufacturing of the customimplant component 618 b as designed by the optimization module 628,e.g., by the surgical robot 602 or other machinery. The manufacturingcan be performed in the operating room 102 (see FIG. 1 ), in a stagingor preparation area adjacent to the operating room 102, or in a facilityon the same premises as the operating room 102. Alternatively, thecustom implant component 618 b can be manufactured in a nearby facilityor remote location. The custom implant component 618 b can beimmediately available for installation upon completion or canalternatively be tested prior to installation. In some embodiments,causing the manufacture of the customized surgical implant component 618b comprises enabling additive manufacturing of the customized surgicalimplant component using a laser sintering three-dimensional (3D) printeror machining the customized surgical implant component using a computernumerical control (CNC) machine. For example, the custom implantcomponent 618 b is a screw manufactured via additive manufacturing via alaser sintering 3D printer in a preparation area adjacent the operatingroom 102. The manufacturing additionally uses a 5-axis CNC mill toremove burrs and uneven surfaces and adds features such as a tulip headby removing material from the 3D printed screw. Further examples includethe modification of a generic implant component 618 a such as addingthreads to a generic rod, or bending a rod or plate.

The optimization module 628 can generate parameters, dimensions, and/orinstructions or files for manufacturing items, such as customizedimplant components 618 b. In some embodiments, the optimization module628 generates a three-dimensional model of the customized implantcomponent 618 b that is transmitted to an onsite or offsitemanufacturing system. Example manufacturing system can include, withoutlimitation, one or more printers (e.g., additive manufacturingprinters), milling machines, molding machines, lathes, extruders, and/orother manufacturing equipment disclosed herein. In some embodiments, theoptimization module 628 generates three-dimensional CAD or CAM modelsthat are transmitted to the manufacturing system. The manufacturingsystem can determine manufacturing instructions executable tomanufacture the customized implant component 618 b. In some embodiments,the optimization module 628 generates and send machine executableinstructions to instruct the manufacturing equipment to produce thecustomized implant component 618 b.

In some embodiments, one or more processors of the system of FIG. 6determine the absence of the customized surgical implant component 618 bin an inventory. For example, in step 822, the assembly module 624 canorder a custom implant component 618 b if the manufacturing capabilitiesrequired to manufacture the implant component 618 b do not exist onsite. Similarly, the assembly module 624 orders the custom implantcomponent 618 b if there is insufficient stock of raw materials on site.The assembly module 624 orders a compatible generic component 618 a thatis not immediately available according to the inventory database 630.For example, the implant component 618 b is a screw requiring a castingof titanium and such capabilities are unavailable on site. Thus, theassembly module 624 orders the screw from a third-party vendor.

In step 824, the assembly module 624 receives information indicatingthat the custom implant component 618 b has been delivered from athird-party vendor. The implant component 618 b can be delivered via acommercial delivery service or courier. The assembly module 624 enablesinspecting and testing the implant component 618 b to ensure that theimplant component 618 b matches the design specification identified bythe optimization module 628. For example, the implant component 618 b isa 1.5-inch titanium screw with 18 threads per inch and a tulip head andthe inspection process includes visual inspection and testing that thethread is compatible with the receiving hardware such as a rod intendedto be mated to the tulip head of the screw.

In step 826, the assembly module 624 adds the implant component 618 b tothe kit. For example, the implant component 618 b can be a screw, rod,plate, or volume. In another example, the implant component 618 b can bea tool or accessory for use during an implantation procedure to enablethe insertion of the implant component 618 b.

In step 828, the assembly module 624 updates the implant database 622with the implant component 618 b, its design specifications, and whetherthe part was sourced from available generic components 618 a oralternatively was custom manufactured. In step 824, the assembly module624 further indicates the implant 616 of which the implant component 618b is a part and the patient in whom it is to be installed. Additionally,the assembly module 624 updates the implant database 622 with any toolpaths and implantation parameters which can be used to install theimplant component 618 b. For example, the database 622 is updated with a1.5-inch titanium screw with 18 threads per inch and a tulip head to beimplanted in a 66-inch tall, 57-year-old female with osteoporosis.

In step 830, the assembly module 624 determines whether the kit assemblyis complete. The kit assembly is complete if there are no remainingimplant components 618 or tools in the implantation plan that need to beselected and added to the kit. If more implant components 618 remain,the assembly module 624 returns to step 808 and selects another implantcomponent from the implantation plan. For example, additional implantcomponents 618 remain, therefore the kit assembly is not complete.

In step 832, the assembly module 624 terminates the kit assembly whenall implant components 618 and tools in the implantation plan have beenselected, customized, and added to the kit.

The method of FIG. 8 can be used to assemble implant kits, instrumentkits, and other surgical kits. Example implant kits can include, withoutlimitation, an instrument tray or case containing one or more assembledor unassembled implants. Example instrument kits can include, withoutlimitation, an instrument tray or case containing one or more cannulas,obturators, hooks, scissors, clips, spreaders, scalpels, alignmentguides (e.g., scope guides, endoscope guides, bronchoscope guides),drivers, irrigators, cautery hooks, dissectors, etc. Example surgicalkits can contain, without limitation, one or more implants, instruments,and other items and components disclosed herein. Examples of surgicalimplants include, but are not limited to, screws (e.g., locking screws,spinal screws, pedicle screws, bone screws, facet screws), interbodyimplant devices (e.g., intervertebral implants, cages), fusion devices,plates, rods, disks (e.g., an artificial articulating disk), spacers(e.g., interspinous spacers, fixed body spacers), rods, expandabledevices, stents, brackets, ties, scaffolds, fixation devices (e.g.,plates/rod/screw assemblies, anchor plates, etc.), bolts, fasteners,joint replacements, knee joints, hip implants, or the like. Examples ofinstruments include, but are not limited to, cannulas, ports, imagingdevices, screw guides, spreaders, insertion tools, or the like. Kits canbe assembled locally (e.g., onsite at a healthcare facility, a surgicalroom, or another suitable location) using local inventory, locallymanufactured items, off-site manufactured items, etc. The kits can besterilized and then provided to the surgical team. FIG. 4A shows twosurgical kits 453 a, 453 b in the surgical room for performing surgicalprocedures and can include components discussed herein.

The methods disclosed herein can include receiving, via a computersystem, patient data of the patient, monitoring data, and other datadisclosed herein. The computing system can determine a patient-sizedcomponent based on the received patient data. The received patient datacan include, without limitation, images, physician notes, or otherpatient data disclosed herein. The computing system can determinewhether the patient-sized component is in inventory based on aninventory database 630. The inventory database 630 can include a numberof implants, manufacturer information, sizes of implants, implantcomponents, and other inventory information. For example, the inventorydatabase 630 includes a list of available implants of different sizesfor a particular procedure. The computing system can determine whetherthe patient-sized components in inventory are suitable for a plannedprocedure.

In response to determining that a suitable patient-sized component isnot in inventory, the computing system can cause a suitablepatient-sized component to be acquired. In some embodiments, in responseto determining that the patient-sized component is absent from theinventory, the computing system causes the patient-sized component to bemanufactured. Advantageously, the patient-sized component can becustomized to the patient's dimensions to provide a patient-specificcomponent, implant, instrument, etc.

In response to the patient-sized component being in inventory, thecomputing system can analyze scheduled procedures for other patients toidentify one or more of the scheduled procedures in which thepatient-sized components are suitable. The computing system canprioritize and assign the available patient-sized components to theappropriate patients. The computing system can then cause additionalpatient-sized components (e.g., standard or patient-specific components)to be ordered or manufactured for other patients. This allows forflexibility when scheduling procedures and selecting suitable componentsof kits.

In some embodiments, the computing system determines whether to reservea patient-sized component for the identified one or more patients basedon the number of patient-sized components being in inventory andpredicted outcomes for each of the one or more patients. The outcomescan be used to assign patient components to patients. For example, ifthe predicted outcome for a patient is below a threshold score, thecomputing system can develop an implantation plan and design one or morepatient-specific components to increase the outcome score for theprocedure. This allows the computing system to ensure that predictedoutcomes for scheduled procedures are predicted to be at or above athreshold outcome score.

The computing system can also analyze surgical plans to determine one ormore steps of the surgical plan based on an identified surgical robotscheduled for surgery. The components can be assembled into a surgicalkit used by the surgical team to prepare the surgical robot for surgery.In some embodiments, the computing system can determine potentialadverse events, alternative surgical steps, component malfunction, etc.and recommend auxiliary or stand-by kits. The auxiliary or stand-by kitscan include, without limitation, one or more instruments, implants,components of implants (e.g., unassembled implants, partially assembledimplants, etc.), robotic tools, surgical equipment, or combinationsthereof.

In some embodiments, the system identifies one or more components ininventory suitable for a surgical plan based on virtual modeling orsimulations. The system can select the components (e.g., patient-sizedcomponents, patient-specific components, etc.) based on compatibility ofthe patient-sized component with other available components for asurgical kit. For example, the system can perform simulations usingavailable equipment (e.g., surgical instruments in inventory). Based onthe simulations, the system can determine additional instruments,implants, or other equipment suitable for the procedure. This enablesthe system to provide surgical kits based on available componentsaccording to the surgical plan. The system can base the analysis onhistorical treatment information retrieved from a historical treatmentdatabase.

For pre-operative kit assemblies, the system can schedule manufacturingof components of kits such that the kits can be assembled and sterilizedbefore scheduled start times for surgical procedures. If the systemreceives notification of manufacturing delays, the surgical system canautomatically notify the healthcare provider, patient, and otherindividuals to reschedule the surgery. In some embodiments, thehealthcare provider schedules surgical procedures based on amanufacturing schedule for patient-sized components, the patientconditions, or other input parameters. Manufacturing schedules can bemodified based on the priority of the conditions of the scheduledpatients. This allows flexibility to prioritize patients based on thecondition of the patients. For intra-operative kit assemblies, thesystem can determine the number and configuration of kits to be providedbased on, for example, real-time monitoring data, identified events,and/or physician input (e.g., input for new surgical steps, alternativetechniques, etc.). For example, unplanned adverse event(s) may requireadditional surgical steps to be performed. The system can design inreal-time kits for those surgical steps using on-site manufacturingequipment. The system can intra-operatively design components of the kitbased on the on-site manufacturing capabilities. In some embodiments,the system can determine risk scores for adverse event(s), or otherevents, during the surgical procedure and can provide surgical kits (orcomponents of kits) when the risk score(s) reach threshold score(s). Thesurgical kits are then available if needed by the surgical team. In suchprocedures, the system may include manufacturing equipment near to or atthe surgical room. The system can receive data before and/or during thesurgical procedure and can use received data to, for example, recommend,design (pre-operatively and/or intra-operatively design), and/or providecomponents, implants, instructions, and/or kit assemblies.

FIG. 9 is a flow diagram illustrating an example process for customizedkit assembly for surgical implants, in accordance with one or moreembodiments. In some embodiments, the process of FIG. 9 is performed bythe planning module 626. The planning module 626 is illustrated anddescribed in more detail with reference to FIG. 6 . In otherembodiments, the process of FIG. 9 is performed by a computer system,e.g., the example computer system 300 illustrated and described in moredetail with reference to FIG. 3 . Particular entities, for example, theconsole 108 or the robotic surgical system 160 perform some or all ofthe steps of the process in other embodiments. The console 108 and therobotic surgical system 160 are illustrated and described in more detailwith reference to FIG. 1 . Likewise, embodiments can include differentand/or additional steps, or perform the steps in different orders.

In step 902, the planning module 626 receives patient data from theassembly module 624. The patient data includes any of gender, age,height, weight, allergies, current or prior medical conditions, or anyadditional clinical information which may impact the outcome of theimplantation procedure. Patient data can additionally include vitalinformation such as the patient's blood pressure, heart rate, bloodoxygen saturation, respiration rate, etc. For example, the patient dataindicate that the patient is female, 66 inches tall, and hasosteoporosis.

In step 904, the planning module 626 queries the implant database 622for data from previously installed implants 616. The data includesprevious designs for implants, previous implant components, previousimplantation parameters, and previous tool paths. The implantationparameters retrieved can include direction and speed of movement of aprevious surgical tool or implant component as well as operationalparameters such as rotational speed or axial force exerted by the toolor implant component, and tool alignment. For example, an example ofdata stored in the implant database 622 describes a screw that is 2inches long with a diameter of 0.25 inches and is made of stainlesssteel. The data can further describe that the screw has 24 threads perinch and is installed one inch to the left of the spinous process in theT-6 vertebra of a 75-inch tall, 64-year-old male. Further, the screw wasinserted with a rotational speed of 25 rotations per minute, an axialforce of 3 pounds per square inch, and an alignment angle of 15 degreesoff center.

In step 906, the planning module 626 enables imaging the patient usingat least one imaging device 614 such as magnetic resonance imaging,computer aided tomography, or ultrasound. The imaging includes at leastthe site on the patient's body receiving the implant 616 and asurrounding area. Alternatively, the imaging includes the entirety ofthe patient's body. In some embodiments, generating the images of aportion of the particular patient's body comprises capturing imageslices of the portion of the particular patient's body at differentdepths using magnetic resonance imaging (MRI) and layering the imageslices to provide a 3D virtual model. For example, the patient is imagedusing magnetic resonance imaging such that multiple images are takenrepresenting slices at varying depths.

In some embodiments, generating an implantation plan comprisesgenerating, by one or more processors of the system of FIG. 6 , avirtual model of a portion of a particular patient's body based on theimages. The one or more processors place a model of the customizedversion of the surgical implant 616 in the virtual model to determinethe implantation parameters. The implantation parameters comprise aspeed of inserting the customized surgical implant component 618 b intothe portion of the particular patient's body and a force applied to thecustomized surgical implant component 618 b. For example, in step 908,the planning module 626 generates a virtual model of a portion of thepatient's body using the images captured of the patient using the atleast one imaging device 614. The virtual model can be two dimensionalor three dimensional. In some embodiments, one or more processors of thesystem of FIG. 6 animate the 3D virtual model using movement of theparticular patient's body over time to provide a four-dimensional (4D)virtual model. The virtual model can include a fourth dimension of timesuch that the model can be animated to represent movement of thepatient's body over a period of time. For example, multiple magneticresonance imaging slices are layered to create a three-dimensionalvirtual model of the patient's spine and surrounding tissues inpreparation of performing a spinal 360 fusion procedure via theinsertion of an implant 616 fusing three vertebrae together.

In step 910, the planning module 626 selects the implant components 618which will make up the implant 616. The implant 616 can include a singleimplant component 618 a or an assembly of multiple implant components618. An assembly can be implanted as a single unit or can requireimplantation in multiple discrete pieces to form the final implant 616.Use of an assembly can improve functionality of the implant 616, such asarticulation or flexibility, or can facilitate the insertion of theimplant 616 such that the assembled implant 616 is more rigid withlittle or no flexibility. Selection of the implant components 618further includes selecting the material which each implant component 618a is to be made of. For example, the implant components 618 make up aspinal implant 616 and include six screws, each with a head known as a“tulip” to receive one of two rods and two plates to join the two rodstogether to prevent movement relative to one another. All of the implantcomponents 618 are made of titanium.

In step 912, the planning module 626 places a model of the at least oneimplant 616 in or on the virtual model of the patient's body. The modelof the implants 616 are placed in the virtual model as they would be bya surgeon or the surgical robot 602 in or on the patient's body. Forexample, a spinal implant is inserted into a three-dimensional model ofa patient's thoracic spine to fuse three vertebrae to one another. Thespinal implant includes at least two screws inserted 1 inch into eachvertebra, one on either side of the spinous process and perpendicular tothe surface of the vertebrae. Additionally, two rods located on eitherside of the spinous process are each secured to the screws on itsrespective side of the spinous process via a tulip. Two plates connectthe two rods to one another to prevent the rods from moving relative toone another.

In step 914, the planning module 626 generates tool paths andimplantation parameters for each implant component 618. The implantationparameters action as instructions for a surgeon or the surgical robot602 to aid the insertion of the implant components 618 and canadditionally include design parameters to be used in the selection of animplant component 618 a or the manufacture of custom implant components116 b. In some embodiments, the end effector 606 of the surgical robot602 inserts the customized version of the surgical implant 616 from thekit into a portion of a particular patient's body for a particulartreatment or medical application or procedure according to theimplantation parameters. For example, a tool path includes moving a rod,for implantation along the spine of the patient, into the incision siteand parallel to the spine until it is in position alongside the spinousprocess and above the screws. The rod is further engaged with the tulipon the head of each screw. In step 914, the planning module 626 furthergenerates implantation parameters, such as the rate of movement of animplant component 618 a through the patient's body, the orientation ofthe implant component 618 a, and the force which should be applied toengage the rod with the screws. For example, the planning module 626specifies that the implant component 618 a should be moved within thepatient's body by pushing the rod lengthwise into the incision to thesurgical site until it is in position at a rate not to exceed 2 inchesper minute. Continuing the example, when the rod is positioned above thescrews it is intended to engage, the planning module 626 specifies thata force should be applied perpendicular to the rod not to exceed 5pounds per square inch until the rod engages the screw heads. Further,the rod should be 3.5 inches long and 0.375 inches in diameter.

In step 916, the planning module 626 returns control to the assemblymodule 624 when the implant components 618 have been selected and placedin a virtual model of the patient, and the tool path, implantationparameters, design of the implant components 618, and manufacturingparameters have been generated. The implant components 618, theirplacement, the tool paths, implantation parameters, and the design andmanufacturing parameters for the implant components 618 are included inan implantation plan.

FIG. 10 is a flow diagram illustrating an example process for customizedkit assembly for surgical implants, in accordance with one or moreembodiments. In some embodiments, the process of FIG. 10 is performed bythe optimization module 628. The optimization module 628 is illustratedand described in more detail with reference to FIG. 6 . In otherembodiments, the process of FIG. 10 is performed by a computer system,e.g., the example computer system 300 illustrated and described in moredetail with reference to FIG. 3 . Particular entities, for example, theconsole 108 or the robotic surgical system 160 perform some or all ofthe steps of the process in other embodiments. The console 108 and therobotic surgical system 160 are illustrated and described in more detailwith reference to FIG. 1 . Likewise, embodiments can include differentand/or additional steps, or perform the steps in different orders.

In step 1002, the optimization module 628 receives informationdescribing an implant component 618 from the assembly module 624. Theimplant component 618 is specified by an implantation plan generated bythe planning module 626. The information describing the implantcomponent 618 includes parameters such as the type of component andphysical dimensions, and can further specify the material andmanufacturing process. The information describing the implant component618 can additionally include tool paths and implantation parameters tobe used by a surgeon or the surgical robot 602 to insert the implantcomponent 618. For example, the implant component 618 is a screw with atulip head intended to be installed 1 inch to the left of the spinousprocess of the T6 vertebra as part of an implant 616 to perform a fusion360 procedure. The screw is 1 inch long with 24 threads per inch.

In step 1004, the optimization module 628 receives patient dataindicating any of gender, age, height, weight, allergies, current orprior medical conditions, or any additional clinical information thatcan impact the outcome of the implantation procedure. Patient data canadditionally include vital information such as the patient's bloodpressure, heart rate, blood oxygen saturation, respiration rate, etc.The patient data can additionally describe the virtual model created bythe planning module 626. For example, the patient data indicates thatthe patient is female, 66 inches tall, and has osteoporosis.

In step 1006, the optimization module 628 queries the implant database622 for data from previously installed implants. The data retrieved caninclude designs for previously inserted implants, the previous implantcomponents, previous implantation parameters, and tool paths. Theimplantation parameters can include the direction and speed of movementof a previously used surgical tool 154 or implant component as well asoperational parameters such as rotational speed, axial force exerted bythe tool 154, or tool alignment. For example, an example of data storedin the implant database 622 describes a screw that is 2 inches long witha diameter of 0.25 inches and is made of stainless steel. The data canfurther specify that the screw has 24 threads per inch and is installedone inch to the left of the spinous process in the T6 vertebra of a75-inch tall, 64-year-old male. Further, the screw was inserted with arotational speed of 25 rotations per minute, an axial force of 3 poundsper square inch, and an alignment angle of 15 degrees off center.

In step 1008, the optimization module 628 determines whether the patientdata indicates that the patient has any special medical conditions suchas osteoporosis, hypertension, hypotension, anemia, etc., that canimpact the type of implant 616 used, how the implant 616 is to besecured within the patient's body, or adjustments which can need to bemade to tool pathing to accommodate the patient's conditions. Forexample, the patient is confirmed to have osteoporosis.

In step 1010, the optimization module 628 reduces the data set retrievedfrom the implant database 622 by applying a filter for patientsreceiving implants who have been diagnosed with the same specialconditions afflicting the current patient. For example, the optimizationmodule 628 filters the data from the implant database 622 for previousimplants installed in patients who were also diagnosed withosteoporosis. In further embodiments, the data set can be expanded ifinsufficient data remains after applying a filter such as age, gender,weight, height, etc.

In step 1012, the optimization module 628 customizes the implantcomponent 618's materials. The materials can include any of metal, metalalloy, plastic, ceramic, etc., that have been deemed safe forimplantation into a patient's body. The implant component 618 caninclude a single material, or alternatively, an assembly of multiplematerials, such as a screw made of surgical steel with a movable tuliphead which can be made of a titanium alloy. The material beingcustomized is based on factors including patient allergies, a need tomaximize strength of the implant component 618, a feature of the implantcomponent 618, or a need to minimize the size of the implant component618. For example, a screw is customized by selecting titanium instead ofstainless steel to increase strength while reducing size. Customizingthe implant component 618's materials can further provide for a methodof manufacture, such as whether the implant component 618 should beformed via casting, extrusion, milling, etc. For example, theoptimization module 628 indicates that a screw should be formed vialaser sintering additive manufacturing, or alternatively, via milling.

In some embodiments, designing the customized version of the surgicalimplant 616 comprises determining a length, width, and height of thecustomized surgical implant component 618 b. In some embodiments,designing the customized version of the surgical implant 616 comprisesdetermining threads or a head of a screw of the customized surgicalimplant component 618 b. In some embodiments, designing the customizedversion of the surgical implant 616 comprises determining a cut or abend of the customized surgical implant component 618 b. For example, instep 1014, the optimization module 628 customizes the implant component118's physical features. The physical features can include physicaldimensions such as length, width, height or depth, diameter, etc. Thephysical features can additionally refer to elements of the implantcomponent 618, such as the threads or head of a screw. The physicalfeatures can additionally include cuts, bends, or other physicalmodifications to the implant component 618. The implant component 618can be customized based on factors including patient conditions such asosteoporosis, strength of the implant component 618, a feature of theimplant component 618, or the size of the implant component 618.

For example, a patient has osteoporosis and therefore a screw iselongated from 1 inch to 1.5 inches and the threads per inch are reducedfrom 24 to 18. A screw can further be altered by adjusting the gage,length, size or shape of the head, or type of head. A screw can furtherbe altered by adjusting the pitch, thread angle, minor diameter, ormajor diameter of the threads. Similarly, a rod or plate can be alteredby adding or changing a bend in the rod or plate. A rod can further bemodified with a complex curve, or a plate be given a more complexgeometry or be replaced by a volume. Customization of an implantcomponent 618's physical features can further provide for a method ofmanufacture, such as whether the implant component 618 should be formedvia casting, extrusion, milling, etc. For example, in step 1014, theoptimization module 628 further indicates that a screw should be formedvia milling.

In step 1016, the optimization module 628 returns information describingthe customized implant component 618 to the assembly module 624. Theinformation describing the customized implant component 618 specifiesmaterials, physical features, or methods of manufacture of thecustomized implant component 618. For example, the customized implantcomponent 618 is a 1.5-inch-long titanium screw with 18 threads perinch.

FIG. 11 illustrates end effectors for kits, according to an embodiment.The end effectors 1100 can be installed in the robotic systems disclosedherein. The end effectors can include, without limitation, roboticgrippers (illustrated), cutting instruments (e.g., cutters, scalpels, orthe like), drills, cannulas, reamers, rongeurs, scissors, clamps,drills, bits, or the like. The number and configuration of end effectorscan be selected based on the configuration of the robotic system and theprocedure to be performed. The systems disclosed herein select endeffectors to perform one or more the steps in a surgical procedure andcan provide kits. Surgical kit 1101 includes a tray/case 1102 holdingimplants 1104 (e.g., customized implants), screws 1105, drills 1106 (oneidentified), bits, etc. The configuration, components, and features ofthe surgical kit 1101 can be selected based on the surgery andprocedures to be performed.

The functions performed in the processes and methods can be implementedin differing order. Furthermore, the outlined steps and operations areonly provided as examples, and some of the steps and operations may beoptional, combined into fewer steps and operations, or expanded intoadditional steps and operations without detracting from the essence ofthe disclosed embodiments.

The techniques introduced here can be implemented by programmablecircuitry (e.g., one or more microprocessors), software and/or firmware,special-purpose hardwired (i.e., non-programmable) circuitry, or acombination of such forms. Special-purpose circuitry can be in the formof one or more application-specific integrated circuits (ASICs),programmable logic devices (PLDs), field-programmable gate arrays(FPGAs), etc.

The description and drawings herein are illustrative and are not to beconstrued as limiting. Numerous specific details are described toprovide a thorough understanding of the disclosure. However, in certaininstances, well-known details are not described in order to avoidobscuring the description. Further, various modifications can be madewithout deviating from the scope of the embodiments.

The terms used in this specification generally have their ordinarymeanings in the art, within the context of the disclosure, and in thespecific context where each term is used. Certain terms that are used todescribe the disclosure are discussed above, or elsewhere in thespecification, to provide additional guidance to the practitionerregarding the description of the disclosure. For convenience, certainterms can be highlighted, for example using italics and/or quotationmarks. The use of highlighting has no influence on the scope and meaningof a term; the scope and meaning of a term is the same, in the samecontext, whether or not it is highlighted. It will be appreciated thatthe same thing can be said in more than one way. One will recognize that“memory” is one form of a “storage” and that the terms can on occasionbe used interchangeably.

Consequently, alternative language and synonyms can be used for any oneor more of the terms discussed herein, nor is any special significanceto be placed upon whether or not a term is elaborated or discussedherein. Synonyms for certain terms are provided. A recital of one ormore synonyms does not exclude the use of other synonyms. The use ofexamples anywhere in this specification including examples of any termdiscussed herein is illustrative only and is not intended to furtherlimit the scope and meaning of the disclosure or of any exemplifiedterm. Likewise, the disclosure is not limited to various embodimentsgiven in this specification.

It is to be understood that the embodiments and variations shown anddescribed herein are merely illustrative of the principles of thisinvention and that various modifications can be implemented by thoseskilled in the art.

I/we claim:
 1. A computer-implemented method comprising: generating atleast one virtual simulation based on prior patient data for surgicalprocedures similar to a surgical procedure to be performed on a patient;selecting at least one generic surgical implant component and at leastone customized surgical implant component for a surgical implant basedon the at least one virtual simulation, wherein the at least onecustomized surgical implant component is configured for the patient andthe treatment; in response to determining absence of the at least onecustomized surgical implant component in an inventory, causingmanufacture of the at least one customized surgical implant component;and assembling a surgical kit including the at least one genericsurgical implant component from the inventory and the manufactured atleast one customized surgical implant component, wherein the surgicalimplant is configured to be implanted using a surgical robot.
 2. Thecomputer-implemented method of claim 1, further comprising selecting acomponent of the surgical implant based on data from a historicaltreatment database, patient images, or a combination thereof.
 3. Thecomputer-implemented method of claim 2, wherein the historical treatmentdatabase comprises information describing previously inserted surgicalimplants, the information comprising at least one of designs of thepreviously inserted surgical implants, components of the previouslyinserted surgical implants, surgical tool paths for the previouslyinserted surgical implants, or operational parameters of surgical toolsfor the previously inserted surgical implants.4. Thecomputer-implemented method of claim 1, further comprising repeatedlysimulating a surgical step using different tool paths and implantationparameters until a simulated surgical step meets approval criteria. 5.The computer-implemented method of claim 1, further comprising receivingpatient data upon completion of a surgical step.
 6. Thecomputer-implemented method of claim 4, wherein the patient data iscaptured by an imaging device in real-time.
 7. The computer-implementedmethod of claim 1, further comprising assembling, by the surgical robot,a generic surgical implant component and the customized surgical implantcomponent into a kit for inserting the surgical implant into thepatient's body.
 8. The computer-implemented method of claim 1, whereinthe at least one customized surgical implant component is configured forthe patient's anatomy based on at least one of: a length, width, andheight of the at least one customized surgical implant component; threadsize or a head of a screw of the at least one customized surgicalimplant component; or a cut or a bend of the at least one customizedsurgical implant component.
 9. A computer-implemented method comprising:receiving, via a computing system, patient data of a patient;determining, via the computing system, a patient-sized component for asurgical kit based on the received patient data, wherein the surgicalkit is configured for a surgical procedure; determining, via thecomputing system, whether the patient-sized component is in an inventorybased on an inventory database; and in response to determining that thepatient-sized component is absent from the inventory, causing, via thecomputing system, the patient-sized component to be manufactured for thesurgical procedure.
 10. The computer-implemented method of claim 9,further comprising: in response to the patient-sized component being inthe inventory, analyzing scheduled surgical procedures for otherpatients to identify one or more of the scheduled surgical proceduresfor which the patient-sized component is suitable; and determiningwhether to reserve the patient-sized component for the identified one ormore patients based on a number of patient-sized components being in theinventory and predicted outcomes of each of the identified one or morepatients.
 11. The computer-implemented method of claim 9, furthercomprising: analyzing a surgical plan to determine components forrobotically performing one or more steps of the surgical plan based onan identified surgical robot; assembling the determined components intothe surgical kit; and performing the surgical procedure using theidentified surgical robot with the components from the surgical kit. 12.The computer-implemented method of claim 9, wherein the componentsinclude one or more instruments, components of an implant, and/orrobotic tools.
 13. The computer-implemented method of claim 9, whereinthe patient-sized component is a patient-specific component designedbased on one or more images of the patient data.
 14. Thecomputer-implemented method of claim 9, further comprising: in responseto determining that the patient-sized component is in the inventory,determining predicted outcomes for the patient-sized component in theinventory and a patient-specific component available for manufacture;and comparing the predicted outcomes to select the patient-sizedcomponent or the patient-specific component for the surgical kit. 15.The computer-implemented method of claim 9, wherein determining thepatient-sized component for a surgical kit includes: identifying one ormore components in the inventory suitable for the surgical plan,selecting the patient-sized component based on compatibility of theselected patient-sized component with the identified one or morecomponents; and assembling the identified one or more components and theselected patient-sized component into the surgical kit.
 16. Thecomputer-implemented method of claim 9, further comprising schedulingthe manufacturing of the patient-sized component to be completed beforea scheduled start time for the surgical procedure.
 17. Thecomputer-implemented method of claim 9, further comprising schedulingthe surgical procedure based on a manufacturing schedule for thepatient-sized component and a condition of the patient.
 18. A kit designsystem comprising: at least one computer processor; and at least onenon-transitory memory coupled to the at least one computer processor andhaving computer executable instructions that, when executed, cause thekit design system to: receive patient data of a patient; determine apatient-sized component for a surgical kit configured for performing asurgical procedure, based on the received patient data; determinewhether the patient-sized component is in inventory based on aninventory database; and in response to determining that thepatient-sized component is absent from the inventory, cause thepatient-sized component to be manufactured for the surgical procedure.19. The kit design system of claim 18, wherein the actions are performedto pre-operatively design one or more kits.
 20. The kit design system ofclaim 18, wherein the actions are performed to intra-operatively designone or more kits.